510(k) · Cleared
Recalled · Class II · 2018AS-Obgyn Information System; as-Emr System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
As Software, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 2, 2005 as substantially equivalent to K970402 (Digisonics, Inc., 1997) and 2 other predicates after a 43-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 2, 2005
- Review
- 43 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K955092 (1996). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK955092 Accurad Image Management System, Autorad, Regustration Station…Cemax-Icon, Inc. · 1996
- 2 generations backK963610 Aki Compacs Data Compresion Module for Diagnostic ImagesA.L.I. Technologies, Inc. · 1996
- 1 generation backK022877 Observer Ultrasound Reporting and Imaging SystemVision Chips, Inc. · 2003
- This deviceK051639 AS-Obgyn Information System; as-Emr SystemAs Software, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK260205 AS Software Version AseraAS Software, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K260205AS Software Version AseraAS Software, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955092 | Accurad Image Management System, Autorad, Regustration Station, Archive… | Cemax-Icon, Inc. | 1996 | — |
| −2 | K963610 | Aki Compacs Data Compresion Module for Diagnostic Images | A.L.I. Technologies, Inc. | 1996 | — |
| −1 | K022877 | Observer Ultrasound Reporting and Imaging System | Vision Chips, Inc. | 2003 | — |
| 0 (this device) | K051639 | AS-Obgyn Information System; as-Emr System | As Software, Inc. | 2005 | — |
| +1 | K260205 | AS Software Version Asera | AS Software, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970402 | Doctors Review SystemSummary page 1…System Substantial Equivalence: Manafacturer -Device Name 510(k) Number Clearance Date Digisonics, Inc. OB-View (Doctors K970402 Mar. 26 1997 Review System) R4 Telemedicine R4's Remote Fetal K000443… | 1997 |
| * | K000443 | Remote Fetal Medicine Ultrasound SystemSummary page 1…Digisonics, Inc. OB-View (Doctors K970402 Mar. 26 1997 Review System) R4 Telemedicine R4's Remote Fetal K000443 Apr. 24 2000 Systems' Inc. Medicine Ultrasound System Vision Chips, Inc. Observer U… | 2000 |
| * | K022877 | Observer Ultrasound Reporting and Imaging SystemSummary page 1…etal K000443 Apr. 24 2000 Systems' Inc. Medicine Ultrasound System Vision Chips, Inc. Observer Ultrasound K022877 Feb. 5 2003 Reporting and Imaging System… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260205 | AS Software Version Asera | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 20, 2018 | Class II | Z-0118-2019 | Device Design | Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production environment to ensure that ultrasound… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K260205 (AS Software, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K970402.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The AS-OBGYN Information System is intended to automate the management of patient information. The system allows image acquisition, review, document, storage, archive and reporting.
The AS-OBGYN Information System is intended for use by obstetricians, gynecologists, perinatologists, radiologists and cardiologists. The system is designed for use in hospitals and medical offices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051639: AS-Obgyn Information System; as-Emr System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051639
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026