B-Scan— 510(k) K243227
Substantially EquivalentAccutome, Inc. Doing Business AS Keeler USA
FDA 510(k) clearance K243227 for B-Scan, Substantially Equivalent on 2025-07-11. Applicant: Accutome, Inc. Doing Business AS Keeler USA.
Clearance details
- Applicant
- Accutome, Inc. Doing Business AS Keeler USA
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.