Skip to content

Biopsy Accessory for Ultrasound Transducer

by Biosound, Inc.

510(k) K971700

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK971700 Date9 Jul 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ITX
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Biopsy Accessory for Ultrasound Transducer, classified under the Diagnostic Ultrasound category. It is designed to facilitate guided biopsy procedures by attaching to ultrasound transducers, enabling precise needle placement during imaging. The accessory ensures real-time visualization of needle positioning within tissue, improving accuracy and safety during interventions. Its primary function is to bridge ultrasound imaging with interventional techniques, reducing procedural risks and enhancing diagnostic yield.

The accessory is supplied as a reusable component, intended for use in clinical settings such as radiology departments or procedural suites. It is not sterile upon packaging and must be sterilized prior to use, adhering to standard medical device sterilization protocols. Compatibility is specified for traditional ultrasound transducer systems, with no noted MRI safety restrictions. Authorized under FDA 510(k) clearance (K971700), it is regulated under the Radiology advisory committee and falls under the ITX product code classification.

Other devices from Biosound, Inc.

See all devices from Biosound, Inc. →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Biosound Biopsy Accessory for Ultrasound Transducer?

    The accessory is designed to attach to ultrasound transducers and facilitate guided biopsy procedures. It allows real-time visualization of needle placement within tissue during imaging, which significantly improves accuracy and reduces procedural risks by ensuring precise targeting.

  • Is the Biosound Biopsy Accessory for Ultrasound Transducer sterile when packaged?

    No, the device is not sterile upon packaging. It must be sterilized prior to use according to standard medical device sterilization protocols to ensure patient safety and infection control.

  • How is the Biosound Biopsy Accessory for Ultrasound Transducer supplied and intended for use?

    The accessory is supplied as a reusable component, intended for clinical settings such as radiology departments or procedural suites. Its design allows it to be integrated with traditional ultrasound transducer systems, enabling seamless use in interventional procedures.

  • Are there any MRI safety restrictions for this device?

    No MRI safety restrictions are noted for the Biosound Biopsy Accessory for Ultrasound Transducer. However, it is designed specifically for use with ultrasound transducer systems, and compatibility with MRI environments should be confirmed based on the broader procedural setup.

  • What regulatory pathway does this device follow?

    The device is authorized under FDA 510(k) clearance (K971700) and is classified under the Radiology advisory committee. It falls under the ITX product code classification and was determined to be substantially equivalent to a predicate device.