Cleared Traditional

K971700 - BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER

K971700 is an FDA 510(k) clearance for BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER, 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 62-day FDA review.

K971700 · Biosound, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
62d
Days
Class 2
Risk

K971700 is an FDA 510(k) clearance for the BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER. 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 July 9, 1997 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biosound, Inc. devices

FDA 510(k) Submission Details - K971700

510(k) Number K971700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1997
Decision Date July 09, 1997
Days to Decision 62 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 107d · This submission: 62d
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 348
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K971700.
HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM
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SLED, FINGER, HANDLE
K971942 · Biosound Esaote, Inc. · Jul 1997
TRANS VAGINAL NEEDLE GUIDE
K971722 · Protek Medical Products, Inc. · Jul 1997
BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/
K970049 · Cardiovascular Imaging Systems, Inc. · Jun 1997
GENERAL PURPOSE TRANDUCER COVER
K970513 · CIVCO Medical Instruments Co., Inc. · Jun 1997
DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE
K970514 · CIVCO Medical Instruments Co., Inc. · Jun 1997