By modality · OB ultrasound reporting software

OB ultrasound reporting software compared: obstetric ultrasound reporting systems, MFM reporting software, and which hold FDA clearance

The short answer

OB ultrasound reporting software is the system an obstetric, gynecology or maternal fetal medicine practice uses to capture fetal biometry from the ultrasound machine, plot it against growth standards, and produce the signed report. The main United States systems are GE HealthCare ViewPoint 6, AS Software, Digisonics, Sonio and CLICKVIEW. They do not sit in the same FDA category: ViewPoint 6, AS Software and Digisonics clear under product code LLZ, a radiological image processing system, while Sonio holds clearances under IYN and POK, which are diagnostic-aid codes. Federal award records for Digisonics show real system prices from $3,200 to $228,800, median $12,698 across 19 awards. Radiological.ai does not replace a reporting system; it is the assistant layer that triages and drafts on the imaging side of the same workflow.

An obstetric ultrasound report is not a paragraph of prose. It is a structured document built from dozens of measurements that come off the machine, get compared against gestational age standards, and have to arrive in the chart with the percentiles calculated correctly. That is why OB practices buy a reporting system separate from the EMR, and why the buying decision turns on details that a general radiology reporting product never has to handle: which growth references the software ships with, whether it recalculates estimated fetal weight the way your physicians expect, and what happens to a twin study.

Every page one result for this search is a vendor describing its own product, so this page does something none of them do. It compares the systems on their FDA record, with the K number and product code for each one, and prices the category against United States federal contract awards rather than against a range someone invented. The clearance data matters more here than in most software categories, because two of these products make a diagnostic claim and three do not, and that difference decides what your physicians are allowed to rely on. Radiological.ai works upstream of all of it, triaging the worklist and drafting the structured report that the OB system then files.

Last updated September 2026

The Reading Station

Assistant ready

Worklist

SERIES 1 · AX

SLICE 24/64

SAMPLE STUDY

NOT FOR DIAGNOSTIC USE

W 80 · L 40

Structured report

Draft

Run the assistant to draft this report for review.

You review & sign

Illustrative sample · not a real patient study, not a diagnosis

Drafted in · you review & sign Worklist re-prioritized

Decision support for qualified clinicians. Radiological.ai does not provide a diagnosis and is not a substitute for professional judgment.

Run the assistant

Flag · prioritize · draft · you review and sign

X-RAY CT MRI BUILT WITH RADIOLOGISTS

Decision support not a diagnosis

You review & sign

If your question is broader than obstetrics, our page on AI ultrasound reporting covers the general radiology ultrasound workflow, where the report is dictated rather than built from a worksheet, and structured radiology reporting covers the template and discrete-field design that both approaches depend on. For what the whole category costs before you request quotes, see ultrasound reporting software pricing.

Most practices buy this as one line in a larger imaging budget. Radiology software pricing benchmarks the neighbouring categories against the same federal award data used above, radiology information system software covers the scheduling and charge capture upstream of the report, and radiology software contract negotiation covers the renewal and interface terms that decide what year two costs.

Primary source

Which OB ultrasound reporting systems hold an FDA 510(k), and under which product code

Every row below was pulled from the openFDA 510(k) database by applicant name. The K number is the record you can look up yourself. The product code is the part vendors rarely put in a brochure, and it is the part that tells you what the software is cleared to claim.

Product and vendor	Clearances on record	Most recent K number and date	Product code and what it means
ViewPoint 6, GE HealthCare	2 under the ViewPoint 6 name	K241300, July 2, 2024	LLZ, radiological image processing system, 21 CFR 892.2050
AS Software (Version Asera, formerly AS-OBGYN)	2	K260205, February 19, 2026	LLZ, radiological image processing system, 21 CFR 892.2050
Digisonics	3	K970402, March 26, 1997	LLZ, radiological image processing system, 21 CFR 892.2050
Sonio Detect	3	K252433, March 16, 2026	IYN, pulsed Doppler ultrasonic imaging system, 21 CFR 892.1550
Sonio Suspect	2	K261519, June 4, 2026	POK, computer-assisted diagnostic software, 21 CFR 892.2060
Tricefy, Trice Imaging	0	No 510(k) on record	Image sharing and archiving, outside the device pathway
CLICKVIEW	0	No 510(k) on record	Reporting and worksheet software, outside the device pathway

Source: openFDA 510(k) database, queried by applicant name on September 8, 2026. Read a zero correctly: reporting software that captures measurements and produces a document is not a diagnostic device and does not need a clearance, so an absent 510(k) is not a defect. What the codes do tell you is the nature of the claim. LLZ covers processing and displaying images and data. POK covers software that helps characterize a finding, which is a diagnostic aid and a materially different product. One caution from building this table: searching the FDA database by device name for ViewPoint also returns the Centerline Biomedical IOPS Viewpoint surgical navigation system, which is an unrelated product from an unrelated company, and searching by applicant for Trice returns Trice Medical, an orthopedic instrument maker rather than Trice Imaging. Always confirm the applicant name on the record before attributing a clearance to a vendor.

Why it works

What your group gets with OB ultrasound reporting software

Two of these products make a diagnostic claim and three do not

This is the single most useful thing on the page and it takes thirty seconds to verify. ViewPoint 6, AS Software and Digisonics all clear under product code LLZ, which is the radiological image processing classification at 21 CFR 892.2050. That covers moving images and measurements around, displaying them and producing a document. It says nothing about interpretation. Sonio is in a different position: Sonio Detect clears under IYN and Sonio Suspect under POK, the computer-assisted diagnostic software classification at 21 CFR 892.2060, and the June 2026 Sonio Suspect clearance K261519 was granted as a Special 510(k), which is the pathway used for a modification to a device the same company already had cleared. If a vendor tells you its software helps identify an anomaly, ask which K number covers that specific claim. A platform-level LLZ clearance does not.

Growth standards and gestational age math decide more disputes than the interface does

The measurements are the easy part. Every one of these systems will pull biometry off the machine over DICOM structured reporting. What varies, and what your physicians will argue about in month two, is what the software does next. Which fetal growth references are installed, and can you add the one your practice actually uses. How estimated fetal weight is calculated and whether the formula is selectable. What happens when the dating study and the current study disagree on gestational age. How twins and higher order multiples are handled on a growth chart. Whether an amended report after a corrected date recalculates every downstream percentile or leaves them stale. Put those five questions in writing before the demo and score every vendor on the same answers, because none of them appear on a feature grid and all of them show up in daily use.

Buy the interfaces, not the screenshots

An OB reporting system that does not connect cleanly is a second place to type. The integration list that matters is short and specific: DICOM structured report capture from each ultrasound machine model you own, including the older ones, because that is usually where it breaks; an HL7 or FHIR results interface into your EMR that carries discrete values rather than a flat PDF; an ADT feed so worklists populate without manual entry; and an image link the EMR can resolve. Ask for the names of practices running your exact machine models and your exact EMR version, and ask what the interface build cost and how long it took. Interface work is where the implementation budget goes, and it is almost never in the software quote you are comparing.

What it handles

Flagged, prioritized and drafted for your review

The assistant pre-reads each study, surfaces a region of interest for review, re-prioritizes the worklist, and drafts the structured report in your template. You confirm, edit and sign.

Triages the imaging worklist so suspected time-critical studies surface first
Flags suspected findings for the physician to review before the report is signed
Drafts the structured report into your own template, with the assessment fields populated
Hands a consistently coded report to whichever reporting system files it
Connects over standard DICOM and HL7 alongside your existing PACS and RIS
The physician reviews every flag and signs every report

OB ULTRASOUND REPORTING SOFTWARE STAT

Region of interest flagged for review

A focal region is surfaced on the sample study for the radiologist to review. The assistant does not characterize it as a diagnosis.

Draft impression

Suspected finding flagged for radiologist review. Correlate clinically and confirm. Draft for review and sign-off.

Illustrative sample · not for diagnostic use You review & sign

Why Radiological.ai

One assistant across the whole read

Not three vendors stitched together. Flag, prioritize and draft in one calm pane, on X-ray, CT and MRI, with the radiologist signing every study.

Flags suspected findings

A second set of eyes surfaces regions of interest for review on every study, so a suspected finding is less likely to slip past late in a shift.

Prioritizes the worklist

Suspected-critical studies move to the top, so urgent reads surface ahead of routine follow-ups across your sites and shifts.

Drafts the report

A structured draft arrives in your template, ready to edit and sign. The draft saves the typing and the measuring, never the judgment.

Good questions

Questions about OB ultrasound reporting software

It is the system an obstetric or maternal fetal medicine practice uses to turn an ultrasound study into a signed report. It captures fetal biometry from the machine over DICOM, plots those measurements against gestational age growth references, calculates estimated fetal weight and percentiles, and produces the document that goes to the chart and the referrer. It sits between the ultrasound machine and the EMR, and it is normally bought separately from both.

All of the established systems except the image sharing tools. GE HealthCare ViewPoint 6 holds K241300, cleared July 2, 2024. AS Software holds K260205, cleared February 19, 2026. Digisonics holds three clearances, the most recent K970402. All three sit under product code LLZ. Sonio is the exception in kind rather than degree: Sonio Detect clears under IYN and Sonio Suspect under POK, which are diagnostic-aid classifications rather than image processing ones.

No vendor in this category publishes a price, so the only verifiable figures are federal contract awards. Digisonics has 19 prime awards on record between 2007 and 2017 totaling $847,834.47, with a median of $12,698 and a range from $3,200 to $228,800. The largest, VA25715P2991 at $228,800, bought a vascular ultrasound reporting system for the VA in September 2015. Read these as anchors for system scale, not as a quote for your practice.

A PACS stores and displays the images. An OB reporting system holds the measurements and the document. The distinction matters at purchase because the two are priced, interfaced and replaced independently: practices routinely change reporting systems while keeping the PACS, and the biometry that drives a growth chart lives in the reporting system, not in the image archive.

Not inherently. Software that captures measurements and produces a document is a record keeping tool rather than a diagnostic device, which is why Tricefy and CLICKVIEW appear with no 510(k) and why that is not a defect. Clearance becomes relevant the moment a product claims to help identify or characterize a finding. That claim needs its own K number, and the code it clears under tells you what was actually reviewed.

Every established system offers an interface, but the useful question is what crosses it. A PDF dropped into the chart satisfies a checkbox and nothing else. What you want is discrete results over HL7 or FHIR so measurements, gestational age and assessments land as structured fields the EMR can query and report on. Ask for a live reference running your EMR version, and ask separately what the interface build cost.

LLZ is the FDA classification for a radiological image processing system, regulated at 21 CFR 892.2050 as a class II device. It covers software that receives, stores, processes and displays medical images and associated data. Most reporting, PACS and image management products clear under it. It is a broad classification, which is why a clearance under LLZ tells you the software was reviewed, but tells you nothing about any interpretive claim.

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