510(k) K120388
- Device
- INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
- Applicant
- HOLOGIC, INC.
- 510(k) number
- K120388
- Product code
- OXO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-04-06
- Date received
- 2012-02-07
- Regulation
- 892.1650
- Classification name
- Image-intensified Fluoroscopic X-ray System, Mobile
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EILEEN M BOYLE
- Address
- 35 Crosby Dr. Bedford MA US 01730 01730
FDA Registration Numbers#
- 3010398867
- 3021060474
- 3010685285
- 3043048939
- 1222780
- 1037955
- 3005843418
- 3005810333
- 3011347852
- 3015223550
- 1054713
- 3036666444
- 3013099020
- 3010703925
- 3009715136
- 3008284470
- 3027373189
- 3008496839
- 3015276088
- 3017375271
- 3003477135
- 3003768277
- 3035950510
- 3031503890
- 3018077344
- 3012127758
- 3011491794
- 3008044777
- 8030233
- 3005496266
- 3003600763
- 3004977335
- 3011713200
- 3027339477
- 3005877899
- 3011416394
- 3010462278
- 3009001657
- 3012624817
- 1225677
- 3030089787
- 1720753
- 3023003446
- 3005254598
- 3015437189
- 3021059265
- 3018094310
- 1723170
- 3003202425
- 3009196578
- 9613445
- 3006544299
- 3012939903
- 3004198450
- 3010009632
- 3010162973
- 3002466018
- 9681146
- 3000126629
- 3004785967
- 3014279513
- 9611343
- 3033525987
- 3008632256
- 3042175844
- 3016619943
- 3005172103
Source Documents#
Other 510(k) Records For Product Code OXO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252579 | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | 2026-01-14 |
| K253269 | OEC One CFD | Ge Hualun Medical Systems Co. , Ltd. | 2025-11-26 |
| K251004 | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | Hefei Chimed Intelligent Machine Co., Ltd. | 2025-11-06 |
| K250587 | Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025-07-02 |
| K243452 | Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025-01-14 |
| K240828 | OEC One ASD | Ge Hualun Medical Systems Co. , Ltd. | 2024-12-27 |
| K233669 | OEC 3D | Ge Oec Medical Systems, Inc. | 2024-03-28 |
| K213113 | Orthoscan Tau Mini C-Arm | Orthoscan, Inc. | 2021-10-21 |
| K203346 | OEC 3D | Ge Oec Medical Systems, Inc. | 2021-03-05 |
| K192819 | OEC Elite | Ge Oec Medical Systems, Inc. | 2019-11-08 |
| K190024 | Smart-C | Turner Imaging Systems, Inc. | 2019-09-27 |
| K183220 | OrthoScan TAU Mini C-Arm | Orthoscan, Inc. | 2019-06-21 |
| K182626 | OEC One | Ge Hualun Medical Systems Co. , Ltd. | 2018-11-16 |
| K170946 | Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant | Skanray Technologies Private Limited | 2017-11-24 |
| K172550 | OEC Elite | Ge Oec Medical Systems, Inc. | 2017-11-16 |
Legacy Summary#
summary
FDA Review#
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