Cleared Traditional

K812089 - POLAROID RADIOGRAPHIC FILM CASSETTE (FDA 510(k) Clearance)

K812089 · Polaroid Corp. · Radiology device
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Aug 1981
Decision
40d
Days
-
Risk

K812089 is an FDA 510(k) clearance for the POLAROID RADIOGRAPHIC FILM CASSETTE.

Submitted by Polaroid Corp. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 40 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Polaroid Corp. devices

Submission Details

510(k) Number K812089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1981
Decision Date August 31, 1981
Days to Decision 40 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 107d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -