AI-Rad Companion Prostate MR
Summary
Siemens Healthcare GmbH received 510(k) clearance for AI-Rad Companion Prostate MR, a LLZ device. Cleared on 2025-09-09.
Details
Source
510(k) Clearance
External ID
K252608
Action Date
2025-09-09
Status
Traditional
Category
device
Product Code
LLZ
Product Description
AI-Rad Companion Prostate MR. Product code: LLZ.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 413 device clearances issued this month. Siemens Healthcare GmbH has received 21 total clearances in our database.
Siemens Healthcare GmbH has 21 FDA actions in our database, including 21 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 GmbH have FDA actions?
Siemens Healthcare GmbH has 21 FDA actions in our database, including 0 recalls and 21 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K252608" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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