SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 2
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0499-2026 | Class II | Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUO | October 16, 2025 |
| Z-0316-2025 | Class II | SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and | September 6, 2024 |
| Z-0139-2025 | Class II | Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system cons | September 6, 2024 |
| Z-0317-2025 | Class II | The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and | September 6, 2024 |
| Z-1292-2024 | Class II | Shimadzu, Trinias, Digital Angiography System | January 29, 2024 |
| Z-2270-2023 | Class II | Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision | April 10, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240827 | SET-5002 | May 24, 2024 |
| K221922 | Trinias | July 28, 2022 |