Cleared Traditional

K931297 - GCA-7200A

K931297 is an FDA 510(k) clearance for GCA-7200A, manufactured by Toshiba America Medical Systems, In.C. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K931297 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
134d
Days
Class 2
Risk

K931297 is an FDA 510(k) clearance for the GCA-7200A. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on July 27, 1993 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Toshiba America Medical Systems, In.C devices

FDA 510(k) Submission Details - K931297

510(k) Number K931297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1993
Decision Date July 27, 1993
Days to Decision 134 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
27d slower than avg
Panel avg: 107d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 372
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K931297.
MAGELLAN
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C-EQUAL(CEDERS-EMORY QUANTITIVE ANALYSIS)
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CORT-EX
K926133 · General Electric Co. · Jun 1993
OPTITRACK
K924877 · Adac Laboratories · Dec 1992
MAXXUS
K924498 · GE Medical Systems · Dec 1992