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ACUSON X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound System

by Siemens Medical Solutions USA, Inc. Ultrasound Gro

510(k) K121646

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 · Special NumberK121646 Date22 Jun 2012ClearedStatusActive

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  • Withdrawn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
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 ACUSON X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound System is a diagnostic ultrasound imaging system. It is substantially equivalent to a predicate device and received special 510(k) clearance from the FDA.

The system is manufactured by Siemens Medical Solutions USA, Inc. Ultrasound Gro and is authorized under FDA 510(k) clearance K121646. It is intended for use in general radiology, fetal, abdominal, intraoperative, pediatric, and other applications as indicated in the device's labeling and intended use.

Other devices from Siemens Medical Solutions USA, Inc. Ultrasound Gro

Questions

AI-generated answers, 22 Sep 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 ACUSON X150 Diagnostic Ultrasound System Sonovista X150 used for?

    It is intended for use in general radiology, fetal, abdominal, intraoperative, pediatric, and other applications as indicated in the device's labeling and intended use, based on its FDA 510(k) clearance.

  • Who manufactures the ACUSON X150 Diagnostic Ultrasound System Sonovista X150?

    The system is manufactured by Siemens Medical Solutions USA, Inc. Ultrasound Gro, located at 685 E. Middlefield Rd., Mountain View, CA 94043, United States.

  • What regulatory clearance does the ACUSON X150 Diagnostic Ultrasound System Sonovista X150 have?

    It received special 510(k) clearance from the FDA under clearance number K121646, determined to be substantially equivalent to a predicate device.