ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES— 510(k) K912250

Name: FDA 510(k) clearance K912250
Creator: U.S. Food and Drug Administration
Published: 1991-11-05

Substantially Equivalent

Theta Systems, Inc.

FDA 510(k) clearance K912250 for ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES, Substantially Equivalent on 1991-11-05. Applicant: Theta Systems, Inc.. Device class: 2.

Clearance details

Applicant: Theta Systems, Inc.
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 1991-05-21
Decision date: 1991-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

Download summary PDF View on FDA.gov ↗

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K912249 — PATIENT DOSE MONITOR1991-08-30

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