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FDA 510(k)

Atellica IM Total PSA II (tPSAII)

K-Number: K251630 · 2026-01-05

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2026-01-05
Product CodeLTJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Atellica IM Total PSA II (tPSAII) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-01-05 under approval number K251630. The device is classified under product code LTJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atellica IM Total PSA II (tPSAII)?

Atellica IM Total PSA II (tPSAII) is a medical device that received FDA 510(k) clearance on 2026-01-05. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K251630.

When was Atellica IM Total PSA II (tPSAII) approved by the FDA?

Atellica IM Total PSA II (tPSAII) received FDA 510(k) clearance on 2026-01-05, under approval number K251630.

What company makes Atellica IM Total PSA II (tPSAII)?

Atellica IM Total PSA II (tPSAII) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for Atellica IM Total PSA II (tPSAII)?

The FDA product code for Atellica IM Total PSA II (tPSAII) is LTJ.

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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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