HAMAMATSU PET SCANNER, MODEL SHR-22000— 510(k) K982171

Name: FDA 510(k) clearance K982171
Creator: U.S. Food and Drug Administration
Published: 1998-09-17

Substantially Equivalent

Hamamatsu Photonics K.K.

FDA 510(k) clearance K982171 for HAMAMATSU PET SCANNER, MODEL SHR-22000, Substantially Equivalent on 1998-09-17. Applicant: Hamamatsu Photonics K.K.. Device class: 2.

Clearance details

Applicant: Hamamatsu Photonics K.K.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1998-06-19
Decision date: 1998-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, 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.