K231001 is an FDA 510(k) clearance for the DeepTek CXR Analyzer v1.0. This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Deeptek Medical Imaging Pvt, Ltd. (Pune, IN). The FDA issued a Cleared decision on October 5, 2023, 181 days after receiving the submission on April 7, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2070. 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.
| 510(k) Number | K231001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2023 |
| Decision Date | October 05, 2023 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MYN - Analyzer, Medical Image |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2070 |
| Definition | 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 |