Cleared Traditional

NOTEBOOK IMAGER

K961104 · Digirad Corp. · Radiology
May 1997
Decision
434d
Days
Class 1
Risk

About This 510(k) Submission

K961104 is an FDA 510(k) clearance for the NOTEBOOK IMAGER, a Camera, Scintillation (gamma) (Class I — General Controls, product code IYX), submitted by Digirad Corp. (Laurel, US). The FDA issued a Cleared decision on May 28, 1997, 434 days after receiving the submission on March 20, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1100.

Submission Details

510(k) Number K961104 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1996
Decision Date May 28, 1997
Days to Decision 434 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYX — Camera, Scintillation (gamma)
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.1100

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