Cleared Traditional

K828562 - DIGIRAD CFR 2000 RADIOGRAPHIC FILM CASSETTE
(FDA 510(k) Clearance)

K828562 · Digirad Corp. · Radiology device
Apr 1983
Decision
163d
Days
—
Risk

K828562 is an FDA 510(k) clearance for the DIGIRAD CFR 2000 RADIOGRAPHIC FILM CASSETTE..

Submitted by Digirad Corp. (Palo Alto, US). The FDA issued a Cleared decision on April 28, 1983, 163 days after receiving the submission on November 16, 1982.

This device falls under the Radiology FDA review panel.

Submission Details

510(k) Number K828562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1982
Decision Date April 28, 1983
Days to Decision 163 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code —
Device Class —