DeepTek CXR Analyzer v1.0— 510(k) K231001
Substantially EquivalentDeeptek Medical Imaging Pvt, Ltd.
FDA 510(k) clearance K231001 for DeepTek CXR Analyzer v1.0, Substantially Equivalent on 2023-10-05. Applicant: Deeptek Medical Imaging Pvt, Ltd.. Device class: 2.
Clearance details
- Applicant
- Deeptek Medical Imaging Pvt, Ltd.
- Product code
- Code MYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.2070
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pune, IN
Recent devices under product code MYN
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