C-ARM STAND FOR BIPLANCE CINE FLUOROGRAPHY MH-20— 510(k) K875373
Substantially EquivalentShimadzu Precision Instruments, Inc.
FDA 510(k) clearance K875373 for C-ARM STAND FOR BIPLANCE CINE FLUOROGRAPHY MH-20, Substantially Equivalent on 1988-02-12. Applicant: Shimadzu Precision Instruments, Inc..
Clearance details
- Applicant
- Shimadzu Precision Instruments, Inc.
- Product code
- Code IZI
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Torrance, CA, US
Adverse events under product code IZI
product code IZI- Death
- 9
- Malfunction
- 5,312
- Total
- 5,321
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.