aprevo® Digital Planning
FDA 510(k) K242599 · Carlsmed, Inc.
510(k) numberK242599
Submission
- Device name
- aprevo® Digital Planning
- Applicant
- Carlsmed, Inc.
Carlsbad, CA, US - Received
- August 30, 2024
- Decision date
- December 20, 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 aprevo® Digital Planning cleared by the FDA?
aprevo® Digital Planning (K242599) received a 510(k) decision of Substantially Equivalent on December 20, 2024, 112 days after the submission was received.
What is the product code of K242599?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.