Cleared Traditional

K837033 - ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440 (FDA 510(k) Clearance)

K837033 · Radiation Measurements, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1983
Decision
85d
Days
-
Risk

K837033 is an FDA 510(k) clearance for the ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440.

Submitted by Radiation Measurements, Inc. (Middleton, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 85 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 Radiation Measurements, Inc. devices

Submission Details

510(k) Number K837033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1982
Decision Date March 09, 1983
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -