DOCTORS REVIEW SYSTEM— 510(k) K970402

Name: FDA 510(k) clearance K970402
Creator: U.S. Food and Drug Administration
Published: 1997-03-26

Substantially Equivalent

Digisonics, Inc.

FDA 510(k) clearance K970402 for DOCTORS REVIEW SYSTEM, Substantially Equivalent on 1997-03-26. Applicant: Digisonics, Inc.. Device class: 2.

Clearance details

Applicant: Digisonics, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1997-02-03
Decision date: 1997-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K970402

K-number listed on FDA's recall record

Z-2214-2023 — Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting softwareClass II·Ongoing·Digisonics, Inc·20230626

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970402.

Data sourced from openFDA. This site is unofficial and independent of the FDA.