Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
Summary
Canon Medical Systems Corporation received 510(k) clearance for Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i, a JAK device. Cleared on 2023-03-03.
Details
Source
510(k) Clearance
External ID
K222819
Action Date
2023-03-03
Status
Traditional
Category
device
Product Code
JAK
Product Description
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i. Product code: JAK.
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. Canon Medical Systems Corporation has received 43 total clearances in our database.
Canon Medical Systems Corporation has 43 FDA actions in our database, including 43 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 Canon Medical Systems Corporation have FDA actions?
Canon Medical Systems Corporation has 43 FDA actions in our database, including 0 recalls and 43 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K222819" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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