PINNACLE IMAGE PROCESSING SYSTEM— 510(k) K902648

Name: FDA 510(k) clearance K902648
Creator: U.S. Food and Drug Administration
Published: 1990-08-17

Substantially Equivalent

Medasys, Inc.

FDA 510(k) clearance K902648 for PINNACLE IMAGE PROCESSING SYSTEM, Substantially Equivalent on 1990-08-17. Applicant: Medasys, Inc.. Device class: 2.

Clearance details

Applicant: Medasys, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1990-06-15
Decision date: 1990-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

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K875198 — DIGITAL NUCLEAR IMAGING SYSTEM1988-07-01

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 →

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