HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL— 510(k) K991129

Name: FDA 510(k) clearance K991129
Creator: U.S. Food and Drug Administration
Published: 1999-05-13

Substantially Equivalent

Hitachi Medical Corp. of America

FDA 510(k) clearance K991129 for HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL, Substantially Equivalent on 1999-05-13. Applicant: Hitachi Medical Corp. of America. Device class: 2.

Clearance details

Applicant: Hitachi Medical Corp. of America
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1999-04-02
Decision date: 1999-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twinsburg, OH, US

Download summary PDF View on FDA.gov ↗

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