510(k) · Cleared
Recalled · Class II · 2023Doctors Review System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digisonics, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 26, 1997 after a 51-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Mar 26, 1997
- Review
- 51 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 5
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK970402 Doctors Review SystemDigisonics, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK022877 Observer Ultrasound Reporting and Imaging SystemVision Chips, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK051639 AS-Obgyn Information System; as-Emr SystemAs Software, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK260205 AS Software Version AseraAS Software, LLC · 2026
Most influential descendants
Showing 3 of 3 · See all- K022877Observer Ultrasound Reporting and Imaging SystemVision Chips, Inc. · 2003 · cites it directly2descendants
- K051639AS-Obgyn Information System; as-Emr SystemAs Software, Inc. · 2005 · cites it directly1descendant
- K260205AS Software Version AseraAS Software, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970402 | Doctors Review System | Digisonics, Inc. | 1997 | — |
| +1 | K022877 | Observer Ultrasound Reporting and Imaging System | Vision Chips, Inc. | 2003 | — |
| +1 | K051639 | AS-Obgyn Information System; as-Emr System | As Software, Inc. | 2005 | 1 |
| +2 | K260205 | AS Software Version Asera | AS Software, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | — | ATL Nova Microsonics - Image Vue DCR System Named without a submission number | |
| * | — | TomTec - TomTec 90 with Echocardiography Offline Review Named without a submission number | |
| * | — | General Electric - RT 4000 Data Management Center Named without a submission number | |
| * | — | On-Time Medical - Click*View Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2023 | Class II | Z-2214-2023 | Labeling design | Software issue |
| Feb 6, 2009 | Not classified | Z-2193-2011 | Other | Left ventricle volume was inaccurate when the volumes were measured from images having different scales. |
| Jan 20, 2009 | Not classified | Z-2180-2011 | Device Design | Data from one patient's study had the potential for being put into another patient's report. |
| Nov 4, 2008 | Not classified | Z-2166-2011 | Device Design | Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed. |
| Feb 9, 2007 | Not classified | Z-2113-2011 | Other | Study would on occasion have fetal heart rate and/or cervical length on the report that was not entered nor did it belong to that patient. Software displayed incorrect data for fetal heart rate and cervical length in OB ultrasound reports. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022877 (Vision Chips, Inc., 2003) has gone furthest, with 2 descendants of its own.
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 Doctors Review System (DRS) is general purpose, standalone software for creating patient reports. It consists of Digisonics word processing software together with off-the-shelf computer equipment (PC, VCR, printer, etc.). Using the system, the physician reviews data (from other sources), notes clinical observations from sets of menus, and creates patient reports. Optional analysis programs are provided for quantitation of echo and cath lab data. No diagnoses are made by the software. It is not used for therapy or patient monitoring.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970402: Doctors Review System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970402
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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