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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 the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-01-05 under 510(k) 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. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K251630.

When did Atellica IM Total PSA II (tPSAII) receive FDA 510(k) clearance?

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

Who is the listed applicant for Atellica IM Total PSA II (tPSAII)?

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

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.

Other records listing Siemens Healthcare Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253528Atellica IM CA 19-9 IIPMA P930027Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerPMA P010007KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSK261364Atellica CH Acetaminophen 2 (ACTM)PMA P930036KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSPMA P250026Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

View all 87 devices →

Related Devices (Code: LTJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P000027PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERSRoche Diagnostics Corp.PMA P000021PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERSSiemens Healthcare DiagnosticsK162378FREND PSA PLUS (reagent cartridge)Nanoentek USA, Inc.

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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