FDA 510(k)

Biograph Horizon

K-Number: K193178 · 2020-02-12

ApplicantSiemens Medical Solution USA, Inc.

Decision Date2020-02-12

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Biograph Horizon is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solution USA, Inc.. It received FDA 510(k) clearance on 2020-02-12 under 510(k) number K193178. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biograph Horizon?

Biograph Horizon is a medical device that received FDA 510(k) clearance on 2020-02-12. The listed applicant is Siemens Medical Solution USA, Inc.. The 510(k) number is K193178.

When did Biograph Horizon receive FDA 510(k) clearance?

Biograph Horizon received FDA 510(k) clearance on 2020-02-12, under 510(k) number K193178.

Who is the listed applicant for Biograph Horizon?

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

What is the FDA product code for Biograph Horizon?

The FDA product code for Biograph Horizon is KPS.

Related Devices (Code: KPS)

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.

Device Summary

Frequently Asked Questions

Other records listing Siemens Medical Solution USA, Inc. as applicant

Related Devices (Code: KPS)

Official Source