INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
FDA 510(k) clearance K120388 · decided 2012-04-06
Clearance details
- K-number
- K120388
- Device name
- INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-02-07
- Decision date
- 2012-04-06
- Days to decision
- 59 days
- Clearance type
- Special
- Product code
- OXO
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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| Orthoscan VERSA Mini C-Arm (K243452) | Ziehm-Orthoscan, Inc. | 2025-01-14 |
| OEC One ASD (K240828) | Ge Hualun Medical Systems Co. , Ltd. | 2024-12-27 |
| OEC 3D (K233669) | Ge Oec Medical Systems, Inc. | 2024-03-28 |
| Orthoscan Tau Mini C-Arm (K213113) | Orthoscan, Inc. | 2021-10-21 |
| OEC 3D (K203346) | Ge Oec Medical Systems, Inc. | 2021-03-05 |
| OEC Elite (K192819) | Ge Oec Medical Systems, Inc. | 2019-11-08 |
| Smart-C (K190024) | Turner Imaging Systems, Inc. | 2019-09-27 |
Recalls involving this device
No recalls on record reference this clearance.
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