Atellica IM Total PSA II (tPSAII)
Summary
Siemens Healthcare Diagnostics, Inc. received 510(k) clearance for Atellica IM Total PSA II (tPSAII), a LTJ device. Cleared on 2026-01-05.
Details
Source
510(k) Clearance
External ID
K251630
Action Date
2026-01-05
Status
Traditional
Category
device
Product Code
LTJ
Product Description
Atellica IM Total PSA II (tPSAII). Product code: LTJ.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Siemens Healthcare Diagnostics, Inc. has received 24 total clearances in our database.
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Siemens Healthcare Diagnostics, Inc. have FDA actions?
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251630" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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