Cleared Traditional

K853470 - JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2

K853470 is an FDA 510(k) clearance for JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2, manufactured by Toshiba Medical Systems. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K853470 · Toshiba Medical Systems · Radiology device
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Nov 1985
Decision
92d
Days
Class 1
Risk

K853470 is an FDA 510(k) clearance for the JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on November 19, 1985 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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 Medical Systems devices

FDA 510(k) Submission Details - K853470

510(k) Number K853470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1985
Decision Date November 19, 1985
Days to Decision 92 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
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

IYX Device Classification - Class 1, General Controls

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 64
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K853470.
BODYSCAN
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K850397 · Siemens Gammasonics, Inc. · Mar 1985