Cleared Traditional

K851687 - JUMBO DIGITAL GAMMACAMERA GCA-90B

K851687 is an FDA 510(k) clearance for JUMBO DIGITAL GAMMACAMERA GCA-90B, manufactured by Toshiba Medical Systems. The device is a Class 2 Radiology device with product code JWM cleared through the Traditional 510(k) pathway after a 43-day FDA review.

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

FDA 510(k) Submission Details - K851687

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
Combination Product No
PCCP Authorized No
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.

JWM Device Classification - Class 2, Special Controls

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 K851687.
DIGITAL GAMMA CAMERA GCA 601 E
K851685 · Toshiba Medical Systems · Jun 1985
STARCAM DATA ACQUISITION & PROCESSING SYS H3300C
K850885 · General Electric Co. · Jun 1985
DIGITAL GAMMA CAMERA GCA 501S
K851686 · Toshiba Medical Systems · Jun 1985
DOT-A, DOT-AR PXP-E, PXP-ER
K841905 · Siemens Gammasonics, Inc. · Aug 1984
ECT PROCESSOR
K832737 · Siemens Gammasonics, Inc. · Sep 1983
400T ECT SOFTWARE
K812966 · General Electric Co. · Nov 1981