Cleared Traditional

K828574 - NOVO BMC LAB 22A BONE MINERAL CONTENT DETERMINATION IN THE AXIAL SKELETON (FDA 510(k) Clearance)

K828574 · Novo Diagnostic Systems · Radiology device
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Apr 1983
Decision
35d
Days
-
Risk

K828574 is an FDA 510(k) clearance for the NOVO BMC LAB 22A BONE MINERAL CONTENT DETERMINATION IN THE AXIAL SKELETON.

Submitted by Novo Diagnostic Systems (Walker, US). The FDA issued a Cleared decision on April 4, 1983 after a review of 35 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 K828574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1983
Decision Date April 04, 1983
Days to Decision 35 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 107d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -