Cleared Traditional

K875198 - DIGITAL NUCLEAR IMAGING SYSTEM

K875198 is an FDA 510(k) clearance for DIGITAL NUCLEAR IMAGING SYSTEM, manufactured by Medasys, Inc.. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K875198 · Medasys, Inc. · Radiology device
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Jul 1988
Decision
197d
Days
Class 1
Risk

K875198 is an FDA 510(k) clearance for the DIGITAL NUCLEAR IMAGING SYSTEM. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Medasys, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 197 days - an extended review cycle.

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 Medasys, Inc. devices

FDA 510(k) Submission Details - K875198

510(k) Number K875198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1987
Decision Date July 01, 1988
Days to Decision 197 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 107d · This submission: 197d
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 90
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K875198.
MICRODELTA II
K885242 · Siemens Gammasonics, Inc. · Mar 1989
CX250 MOBILE GAMMA CAMERA & DCS CONSOLE
K880878 · Philips Medical Systems (Cleveland), Inc. · Sep 1988
MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A
K881013 · Toshiba Medical Systems · Aug 1988
JUMBO DIGITAL GAMMACAMERA, GCA-901A
K871175 · Toshiba Medical Systems · Mar 1987
BODYSCAN
K870818 · Siemens Gammasonics, Inc. · Mar 1987
WEIGHTED ACQUISITION MODULE
K861637 · Siemens Gammasonics, Inc. · Jun 1986