Cleared Traditional

K901545 - GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM

K901545 is the FDA 510(k) clearance for GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code JWM) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K901545 · Toshiba America Medical Systems, In.C · Radiology device
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Jun 1990
Decision
84d
Days
Class 2
Risk

K901545 is an FDA 510(k) clearance for the GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM. Classified as System, Tomographic, Nuclear (product code JWM), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on June 26, 1990 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1310 - 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 Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K901545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1990
Decision Date June 26, 1990
Days to Decision 84 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWM System, Tomographic, Nuclear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1310
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 - JWM System, Tomographic, Nuclear

All 14
Devices cleared under the same product code (JWM) and FDA review panel - the closest regulatory comparables to K901545.
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ICON
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K874473 · Adac Laboratories · Jul 1988
ADAC MODEL ARC-5000, GAMMA CAMERA
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DIGITAL GAMMA CAMERA GCA 601 E
K851685 · Toshiba Medical Systems · Jun 1985
STARCAM DATA ACQUISITION & PROCESSING SYS H3300C
K850885 · General Electric Co. · Jun 1985