Delta4 Insight
FDA 510(k) K223234 · Scandidos AB
510(k) numberK223234
Submission
- Device name
- Delta4 Insight
- Applicant
- Scandidos AB
Uppsala, SE - Received
- October 19, 2022
- Decision date
- January 16, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Delta4 Insight cleared by the FDA?
Delta4 Insight (K223234) received a 510(k) decision of Substantially Equivalent on January 16, 2024, 454 days after the submission was received.
What is the product code of K223234?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.