FDA 510(k)

ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System

K-Number: K253457 · 2025-11-13

ApplicantSiemens Medical Solutions USA, Inc.

Decision Date2025-11-13

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2025-11-13 under 510(k) number K253457. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System?

ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2025-11-13. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K253457.

When did ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System receive FDA 510(k) clearance?

ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System received FDA 510(k) clearance on 2025-11-13, under 510(k) number K253457.

Who is the listed applicant for ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System?

The FDA product code for ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System is IYN.

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Official Source

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