SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S.— 510(k) K931021
Substantially EquivalentShimadzu Medical Systems
FDA 510(k) clearance K931021 for SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S., Substantially Equivalent on 1994-11-14. Applicant: Shimadzu Medical Systems.
Clearance details
- Applicant
- Shimadzu Medical Systems
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Torrance, CA, 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.