SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-11— 510(k) K874767
Substantially EquivalentShimadzu Precision Instruments, Inc.
FDA 510(k) clearance K874767 for SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-11, Substantially Equivalent on 1988-02-25. Applicant: Shimadzu Precision Instruments, Inc..
Clearance details
- Applicant
- Shimadzu Precision Instruments, Inc.
- Product code
- Code JAK
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Torrance, CA, US
Adverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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.