GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM— 510(k) K901545

Name: FDA 510(k) clearance K901545
Creator: U.S. Food and Drug Administration
Published: 1990-06-26

Substantially Equivalent

Toshiba America Medical Systems, In.C

FDA 510(k) clearance K901545 for GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM, Substantially Equivalent on 1990-06-26. Applicant: Toshiba America Medical Systems, In.C. Device class: 2.

Clearance details

Applicant: Toshiba America Medical Systems, In.C
Product code: Code JWM
Device class: Class 2
Regulation: 21 CFR 892.1310
Advisory panel: Radiology
Date received: 1990-04-03
Decision date: 1990-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

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