K231001
- 510(k) number
- K231001
- Device name
- DeepTek CXR Analyzer v1.0
- Applicant
- Deeptek Medical Imaging Pvt, Ltd. IN
- Product code
- MYN — Analyzer, Medical Image
- Decision date
- 2023-10-05
- Date received
- 2023-04-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K231001.pdf
Official FDA record: K231001
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.