K243227
- 510(k) number
- K243227
- Device name
- B-Scan
- Applicant
- Accutome, Inc. Doing Business AS Keeler USA PA · US
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2025-07-11
- Date received
- 2024-10-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K243227.pdf
Official FDA record: K243227
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.