Siemens Healthcare Diagnostics Inc.LTJClass II

Prostate-specific Antigen (psa) For Management Of Prostate Cancers

Siemens Healthcare Diagnostics Inc.'s record for this product code

MDR events34All time

Recalls1All time

510(k) clearances1All time

Recent MDR events

34 adverse event reports on file

Recalls

1 recall events for this product code

TerminatedUnknown
Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.
View FDA record ↗

510(k) clearances

1 clearances for this product code

K251630Jan 5, 2026
Atellica IM Total PSA II (tPSAII)