Cleared Traditional

K904050 - MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA

K904050 is an FDA 510(k) clearance for MODEL DH-1000 SINGLE DETEC./DUAL DETEC ..., 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 92-day FDA review.

K904050 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Dec 1990
Decision
92d
Days
Class 1
Risk

K904050 is an FDA 510(k) clearance for the MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on December 5, 1990 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.

FDA 510(k) Submission Details - K904050

510(k) Number K904050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1990
Decision Date December 05, 1990
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 129
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K904050 · MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA
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