SubtleREFORMAT (1.x)
FDA 510(k) K233699 · Subtle Medical, Inc.
510(k) numberK233699
Submission
- Device name
- SubtleREFORMAT (1.x)
- Applicant
- Subtle Medical, Inc.
Menlo Park, CA, US - Received
- November 17, 2023
- Decision date
- April 29, 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 SubtleREFORMAT (1.x) cleared by the FDA?
SubtleREFORMAT (1.x) (K233699) received a 510(k) decision of Substantially Equivalent on April 29, 2024, 164 days after the submission was received.
What is the product code of K233699?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.