Cleared Traditional

K880878 - CX250 MOBILE GAMMA CAMERA & DCS CONSOLE

K880878 is an FDA 510(k) clearance for CX250 MOBILE GAMMA CAMERA & DCS CONSOLE, manufactured by Philips Medical Systems (Cleveland), Inc.. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K880878 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Sep 1988
Decision
184d
Days
Class 1
Risk

K880878 is an FDA 510(k) clearance for the CX250 MOBILE GAMMA CAMERA & DCS CONSOLE. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on September 1, 1988 after a review of 184 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 Philips Medical Systems (Cleveland), Inc. devices

FDA 510(k) Submission Details - K880878

510(k) Number K880878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date September 01, 1988
Days to Decision 184 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
77d slower than avg
Panel avg: 107d · This submission: 184d
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 79
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K880878.
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