K232320
- 510(k) number
- K232320
- Device name
- iSR`obot Mona Lisa 2.0
- Applicant
- Biobot Surgical Pte., Ltd. SG
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2023-12-21
- Date received
- 2023-08-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232320.pdf
Official FDA record: K232320
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.