Transpara (2.1.0)
Summary
Screenpoint Medical B.V. received 510(k) clearance for Transpara (2.1.0), a QDQ device. Cleared on 2024-11-25.
Details
Source
510(k) Clearance
External ID
K241831
Action Date
2024-11-25
Status
Traditional
Category
device
Product Code
QDQ
Product Description
Transpara (2.1.0). Product code: QDQ.
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. Screenpoint Medical B.V. has received 3 total clearances in our database.
Screenpoint Medical B.V. has 3 FDA actions in our database, including 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 Screenpoint Medical B.V. have FDA actions?
Screenpoint Medical B.V. has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K241831" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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