DeepContour (V1.0)— 510(k) K232928
Substantially EquivalentWisdom Technologies., Inc.
FDA 510(k) clearance K232928 for DeepContour (V1.0), Substantially Equivalent on 2024-05-07. Applicant: Wisdom Technologies., Inc.. Device class: 2.
Clearance details
- Applicant
- Wisdom Technologies., Inc.
- Product code
- Code QKB
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hefei, CN
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