Siemens Medical Solutions USA, Inc., Ultrasound di

Mountain View, CA, US

Siemens Medical Solutions USA, Inc., Ultrasound DI appears in FDA device records in Mountain View, CA. FDA records list 11 510(k) clearances between 2007-01-05 and 2017-02-09, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 11
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 11 510(k) clearances for Siemens Medical Solutions USA, Inc., Ultrasound di between 2007 and 2017. The busiest year on record is 2007, with 4. The most recent is 2017, with 1.

Clearances by year, as a table

510(k) clearance decisions for Siemens Medical Solutions USA, Inc., Ultrasound di, by decision year
Year	Clearances
2007	4
2008	4
2011	2
2017	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K163289	syngo. CT Single Source Dual Energy (twin beam)	JAK	Substantially Equivalent	2017-02-09
K113179	ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	2011-12-07
K112596	ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	2011-09-16
K081148	SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER	IYO	Substantially Equivalent	2008-12-22
K082142	ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	2008-11-13
K081121	MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM	IYO	Substantially Equivalent	2008-06-04
K080760	ACUSON X300 ULTRASOUND SYSTEM	IYN	Substantially Equivalent	2008-04-25
K072365	SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	2007-10-17
K072090	SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS	IYN	Substantially Equivalent	2007-09-14
K071036	MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM	IYN	Substantially Equivalent	2007-05-16
K063803	ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	2007-01-05

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Siemens Medical Solutions USA, Inc., Ultrasound di edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Siemens Medical Solutions USA, Inc., Ultrasound di. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain