Cleared Traditional

K913209 - ACCESSORY TO GENESIS III (GCFM)

K913209 is an FDA 510(k) clearance for ACCESSORY TO GENESIS III (GCFM), manufactured by Biosound, Inc.. The device is a Class 2 Radiology device with product code DXK cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K913209 · Biosound, Inc. · Radiology device
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May 1992
Decision
301d
Days
Class 2
Risk

K913209 is an FDA 510(k) clearance for the ACCESSORY TO GENESIS III (GCFM). Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on May 15, 1992 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.2330 - 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. Elevated predicate reliance profile. 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 Biosound, Inc. devices

FDA 510(k) Submission Details - K913209

510(k) Number K913209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1991
Decision Date May 15, 1992
Days to Decision 301 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 107d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXK Device Classification - Class 2, Special Controls

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - DXK Echocardiograph

All 39
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K913209.
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MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832 · Hewlett-Packard Co. · Apr 1991
PATIENT CARE MANAGEMENT SYSTEM MODIFICATION
K910029 · Spacelabs, Inc. · Jan 1991
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K901657 · Hitachi Medical Corp. of America · Sep 1990
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K901658 · Hitachi Medical Corp. of America · Sep 1990