SHIMADZU MOBILE X-RAY SYSTEMS— 510(k) K940294

Substantially Equivalent

Shimadzu Precision Instruments, Inc.

FDA 510(k) clearance K940294 for SHIMADZU MOBILE X-RAY SYSTEMS, Substantially Equivalent on 1994-03-16. Applicant: Shimadzu Precision Instruments, Inc..

Clearance details

Applicant: Shimadzu Precision Instruments, Inc.
Product code: Code OXO
Advisory panel: Radiology
Date received: 1994-01-21
Decision date: 1994-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

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Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.