Cleared Traditional

K770397 - MONITOR, RADIOISOTOPE, MODEL 9273A (FDA 510(k) Clearance)

K770397 · Amersham Corp. · Radiology device
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Mar 1977
Decision
8d
Days
-
Risk

K770397 is an FDA 510(k) clearance for the MONITOR, RADIOISOTOPE, MODEL 9273A.

Submitted by Amersham Corp. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1977 after a review of 8 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.

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Submission Details

510(k) Number K770397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1977
Decision Date March 10, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 107d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -