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Doctors Review System

by Digisonics Inc

510(k) K970402

Doctors Review System is a Class II device made by Digisonics Inc, cleared under FDA 510(k) K970402 on 26 Mar 1997, active as of 22 Oct 2026. 5 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970402 Date26 Mar 1997ClearedStatusActive

Official records

Recalls

5 recalls · 1 ongoing · FDA

    • Ongoing Z-2214-2023 FDA Class II initiated 26 Jun 2023

    Software issue

    • Terminated Z-2193-2011 FDA Unclassified (pre-2012) initiated 6 Feb 2009

    Left ventricle volume was inaccurate when the volumes were measured from images having different scales.

    • Terminated Z-2180-2011 FDA Unclassified (pre-2012) initiated 20 Jan 2009

    Data from one patient's study had the potential for being put into another patient's report.

    • Terminated Z-2166-2011 FDA Unclassified (pre-2012) initiated 4 Nov 2008

    Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed.

    • Terminated Z-2113-2011 FDA Unclassified (pre-2012) initiated 9 Feb 2007

    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.

Timeline

6 dated events

  1. Cleared FDA 510(k) K970402
  2. Recall initiated FDA recalls Z-2113-2011
  3. Recall initiated FDA recalls Z-2166-2011
  4. Recall initiated FDA recalls Z-2180-2011
  5. Recall initiated FDA recalls Z-2193-2011
  6. Recall initiated FDA recalls Z-2214-2023

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LLZ
FDA applicant
Digisonics, Inc.
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

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