Cleared Traditional

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

K828562 · Digirad Corp. · Radiology device
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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 after a review of 163 days - an extended review cycle.

This device falls under the Radiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 107d · This submission: 163d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -