Cleared Traditional

K912088 - BIOPSY ACCESSORIES FOR ULTRASOUND PROBES

K912088 is an FDA 510(k) clearance for BIOPSY ACCESSORIES FOR ULTRASOUND PROBES, manufactured by Biosound, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K912088 · Biosound, Inc. · Radiology device
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Dec 1991
Decision
206d
Days
Class 2
Risk

K912088 is an FDA 510(k) clearance for the BIOPSY ACCESSORIES FOR ULTRASOUND PROBES. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on December 5, 1991 after a review of 206 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Biosound, Inc. devices

FDA 510(k) Submission Details - K912088

510(k) Number K912088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1991
Decision Date December 05, 1991
Days to Decision 206 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
99d slower than avg
Panel avg: 107d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 204
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K912088.
LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM
K913472 · Baxter Healthcare Corp · Mar 1992
CW DOPPLER 2.25 MHZ PROBE
K903562 · Diasonics, Inc. · Mar 1992
PSF-50ET
K910850 · Toshiba America Medical Systems, In.C · Jan 1992
ACUSON V510 TRANSDUCER
K911767 · Acuson Corp. · Oct 1991
ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3
K912363 · Hitachi Medical Corp. of America · Aug 1991
CW DOPPLER/4.5 MHZ
K903984 · Diasonics, Inc. · Jun 1991