Cleared Traditional

K905074 - MICRODELTA

K905074 is an FDA 510(k) clearance for MICRODELTA, manufactured by Siemens Gammasonics, Inc.. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K905074 · Siemens Gammasonics, Inc. · Radiology device
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Jun 1991
Decision
224d
Days
Class 1
Risk

K905074 is an FDA 510(k) clearance for the MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Siemens Gammasonics, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on June 21, 1991 after a review of 224 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 Siemens Gammasonics, Inc. devices

FDA 510(k) Submission Details - K905074

510(k) Number K905074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1990
Decision Date June 21, 1991
Days to Decision 224 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
117d slower than avg
Panel avg: 107d · This submission: 224d
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
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