510(k) K231001
K231001 is an FDA 510(k) premarket notification submitted by Deeptek Medical Imaging Pvt, Ltd. for the device "DeepTek CXR Analyzer v1.0". The FDA issued a decision of Substantially Equivalent on October 5, 2023. The device falls under product code MYN (Analyzer, Medical Image), a Class II device regulated under 21 CFR 892.2070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2023
- Date Received
- April 7, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Medical Image
- Device Class
- Class II
- Regulation Number
- 892.2070
- Review Panel
- RA
- Submission Type
For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers