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Siemens Q64XXX

by Siemens Medical Solutions USA, Inc.

510(k) K950157

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK950157 Date5 Apr 1996ClearedStatusActive

Official records

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  • Withdrawn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
IYO
Device class
Class II
Regulation
21 CFR Part 892.1560
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Siemens Q64XXX is a mobile, software-controlled diagnostic ultrasound system (Product Code: IYO), designed for general radiologic imaging. It features an on-screen display for thermal monitoring and real-time imaging, enabling clinicians to visualize internal body structures using high-frequency sound waves. This device is classified under the Radiology advisory committee and is intended for diagnostic purposes in clinical settings.

The Q64XXX is supplied as a reusable medical device, intended for use in radiology departments and imaging centers. It requires proper maintenance and calibration to ensure accurate performance. Authorized for use in the United States under FDA 510(k) clearance (K950157), the device was granted Substantially Equivalent status in 1996. No specific sterility or MRI safety information is provided in the available data.

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