Cleared Traditional

K951053 - ANGIOREX CAT-350B

K951053 is an FDA 510(k) clearance for ANGIOREX CAT-350B, manufactured by Toshiba America Medical Systems, In.C. The device is a Class 2 Radiology device with product code IZZ cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K951053 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
30d
Days
Class 2
Risk

K951053 is an FDA 510(k) clearance for the ANGIOREX CAT-350B. Classified as Table, Radiographic, Non-tilting, Powered (product code IZZ), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on April 6, 1995 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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.

FDA 510(k) Submission Details - K951053

510(k) Number K951053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1995
Decision Date April 06, 1995
Days to Decision 30 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZZ Device Classification - Class 2, Special Controls

Product Code IZZ Table, Radiographic, Non-tilting, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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.

Regulatory Peers - IZZ Table, Radiographic, Non-tilting, Powered

All 28
Devices cleared under the same product code (IZZ) and FDA review panel - the closest regulatory comparables to K951053.
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ALPHA
K930273 · Raymax Medical Corp. · Jul 1993
B-4 FOUR-WAY RADIOGRAPHIC TABLE
K924444 · Control-X, Inc. · Feb 1993
K951053 · ANGIOREX CAT-350B
Download PDF FDA Summary Toshiba America Medic…