K233634
- 510(k) number
- K233634
- Device name
- TeleScan
- Applicant
- Bb Imaging TX · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2023-12-12
- Date received
- 2023-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233634.pdf
Official FDA record: K233634
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.