Cleared Traditional

K781214 - CAMERAS, MULTI-IMAGE (FDA 510(k) Clearance)

K781214 · Dunn Instruments, Inc. · Radiology device
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Sep 1978
Decision
59d
Days
-
Risk

K781214 is an FDA 510(k) clearance for the CAMERAS, MULTI-IMAGE.

Submitted by Dunn Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1978 after a review of 59 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 Dunn Instruments, Inc. devices

Submission Details

510(k) Number K781214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1978
Decision Date September 14, 1978
Days to Decision 59 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 107d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -