CardIQ Suite
Summary
GE Medical Systems SCS received 510(k) clearance for CardIQ Suite, a JAK device. Cleared on 2024-08-01.
Details
Source
510(k) Clearance
External ID
K233731
Action Date
2024-08-01
Status
Traditional
Category
device
Product Code
JAK
Product Description
CardIQ Suite. Product code: JAK.
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. GE Medical Systems SCS has received 16 total clearances in our database.
GE Medical Systems SCS has 25 FDA actions in our database, including 9 recalls and 16 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 GE Medical Systems SCS have FDA actions?
GE Medical Systems SCS has 25 FDA actions in our database, including 9 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K233731" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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