Cleared Traditional

K843985 - SUSPENSION 7 (FDA 510(k) Clearance)

K843985 · Cgr Medical Corp. · Radiology device
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Nov 1984
Decision
25d
Days
-
Risk

K843985 is an FDA 510(k) clearance for the SUSPENSION 7.

Submitted by Cgr Medical Corp. (Columbia, US). The FDA issued a Cleared decision on November 5, 1984 after a review of 25 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 Cgr Medical Corp. devices

Submission Details

510(k) Number K843985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1984
Decision Date November 05, 1984
Days to Decision 25 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -