Cleared Traditional

K852353 - DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852353 · Thomson-Cgr Medical Corp. · Radiology device
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Aug 1985
Decision
65d
Days
Class 2
Risk

K852353 is an FDA 510(k) clearance for the DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by Thomson-Cgr Medical Corp. (Columbia, US). The FDA issued a Cleared decision on August 7, 1985 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5710 - the FDA radiology and imaging software oversight framework. 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 Thomson-Cgr Medical Corp. devices

Submission Details

510(k) Number K852353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1985
Decision Date August 07, 1985
Days to Decision 65 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 107d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXI Block, Beam-shaping, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5710
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.