# K970402: Doctors Review System

- Pathway: 510(k) (Traditional)
- Applicant: Digisonics, Inc.
- Decided: Mar 26, 1997 after 51 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ATL Nova Microsonics - Image Vue DCR System: named in the summary without a submission number
- (no number) TomTec - TomTec 90 with Echocardiography Offline Review: named in the summary without a submission number
- (no number) General Electric - RT 4000 Data Management Center: named in the summary without a submission number
- (no number) On-Time Medical - Click*View: named in the summary without a submission number

## Most influential descendants
- K022877: Observer Ultrasound Reporting and Imaging System (2003), 2 descendants of its own
- K051639: AS-Obgyn Information System; as-Emr System (2005), 1 descendant of its own
- K260205: AS Software Version Asera (2026), 0 descendants of its own

## Recalls of this device
- Jun 26, 2023 · Class II · Z-2214-2023: Software issue
- Feb 6, 2009 · Not classified · Z-2193-2011: Left ventricle volume was inaccurate when the volumes were measured from images having different scales.
- Jan 20, 2009 · Not classified · Z-2180-2011: 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: 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: 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 ce

## Indications for use
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.

Source page: https://510kreport.com/device/K970402
Methodology: https://510kreport.com/methodology