NOTEBOOK IMAGER— 510(k) K961104

Substantially Equivalent

Digirad Corp.

FDA 510(k) clearance K961104 for NOTEBOOK IMAGER, Substantially Equivalent on 1997-05-28. Applicant: Digirad Corp.. Device class: 1.

Clearance details

Applicant: Digirad Corp.
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 1996-03-20
Decision date: 1997-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laurel, MD, US

Download summary PDF View on FDA.gov ↗

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