MR Diffusion Perfusion Mismatch V1.0
Summary
Olea Medical received 510(k) clearance for MR Diffusion Perfusion Mismatch V1.0, a LLZ device. Cleared on 2023-01-13.
Details
Source
510(k) Clearance
External ID
K223502
Action Date
2023-01-13
Status
Traditional
Category
device
Product Code
LLZ
Product Description
MR Diffusion Perfusion Mismatch V1.0. 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 403 device clearances issued this month. Olea Medical has received 3 total clearances in our database.
Olea Medical has 4 FDA actions in our database, including 1 recall and 3 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 Olea Medical have FDA actions?
Olea Medical has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K223502" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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