Cleared Traditional

MICRODELTA II (K885242) - FDA 510(k) Clearance

Class I Radiology device.

K885242 · Siemens Gammasonics, Inc. · Radiology device
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Mar 1989
Decision
98d
Days
Class 1
Risk

K885242 is an FDA 510(k) clearance for the MICRODELTA II. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Siemens Gammasonics, Inc. (Des Plaines, US). The FDA issued a Cleared decision on March 30, 1989 after a review of 98 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 Siemens Gammasonics, Inc. devices

Submission Details

510(k) Number K885242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1988
Decision Date March 30, 1989
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 29
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K885242.
ES/ULTRA DISPLAY AND PROCESSING STATION
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K904050 · Philips Medical Systems (Cleveland), Inc. · Dec 1990
CX250 MOBILE GAMMA CAMERA & DCS CONSOLE
K880878 · Philips Medical Systems (Cleveland), Inc. · Sep 1988
STARPORT MODEL H3300AA
K852648 · General Electric Co. · Jan 1986
TOMOGRAPHIC GANTRY
K844218 · General Electric Co. · Mar 1985