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FDA 510(k)

Acuson SC2000 Diagnostic Ultrasound System

K-Number: K211726 · 2021-11-05

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2021-11-05
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Acuson SC2000 Diagnostic Ultrasound System is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2021-11-05 under approval number K211726. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acuson SC2000 Diagnostic Ultrasound System?

Acuson SC2000 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-11-05. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K211726.

When was Acuson SC2000 Diagnostic Ultrasound System approved by the FDA?

Acuson SC2000 Diagnostic Ultrasound System received FDA 510(k) clearance on 2021-11-05, under approval number K211726.

What company makes Acuson SC2000 Diagnostic Ultrasound System?

Acuson SC2000 Diagnostic Ultrasound System is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for Acuson SC2000 Diagnostic Ultrasound System?

The FDA product code for Acuson SC2000 Diagnostic Ultrasound System is IYO.

Related Clinical Trials

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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