Skip to content

Biopsy Transducer

by Siemens Gammasonics, Inc.

510(k) K811843

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 NumberK811843 Date25 Aug 1981ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The Biopsy Transducer is an ultrasound system component designed for use in radiology. It functions as a transducer to facilitate diagnostic imaging and biopsy procedures.

This device is manufactured by Siemens Gammasonics, Inc. and received FDA 510(k) clearance under K811843 in 1981.

Other devices from Siemens Gammasonics, Inc.

See all devices from Siemens Gammasonics, Inc. →