Cleared Traditional

JUMBO DIGITAL GAMMACAMERA GCA-90B (K851687) - FDA 510(k) Clearance

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

K851687 · Toshiba Medical Systems · Radiology device
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Jun 1985
Decision
43d
Days
Class 2
Risk

K851687 is an FDA 510(k) clearance for the JUMBO DIGITAL GAMMACAMERA GCA-90B. Classified as System, Tomographic, Nuclear (product code JWM), Class II - Special Controls.

Submitted by Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on June 5, 1985 after a review of 43 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 Medical Systems devices

Submission Details

510(k) Number K851687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1985
Decision Date June 05, 1985
Days to Decision 43 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 107d · This submission: 43d
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

Devices cleared under the same product code (JWM) and FDA review panel - the closest regulatory comparables to K851687.
GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM
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STAR
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K780368 · Medtronic Vascular · Mar 1978
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