510(k) K243446
- Device
- 3DXR
- Applicant
- GE Medical Systems SCS
- 510(k) number
- K243446
- Product code
- OWB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-25
- Date received
- 2024-11-06
- Regulation
- 892.1650
- Classification name
- Interventional Fluoroscopic X-Ray System
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Ning WEN
- Address
- 283, Rue De La Miniere Buc FR 78530 78530
FDA Registration Numbers
- 3010685285
- 3005843418
- 3005810333
- 3011347852
- 3006128100
- 3014391847
- 3036666444
- 3014343100
- 1056553
- 3011240766
- 3008363989
- 2939520
- 2133772
- 3011491794
- 3008044777
- 8030233
- 3004977335
- 8043933
- 3011416394
- 3009001657
- 1720753
- 1047843
- 3030691709
- 3018094310
- 3021059265
- 3009973505
- 3009196578
- 3006544299
- 9611343
- 3042175844
- 1000181430
- 1052701
- 3025394757
- 3010398867
- 2031966
- 3009144915
- 3021559833
- 3009963139
- 3010703925
- 3027373189
- 3015276088
- 3035950510
- 3018077344
- 3033527770
- 9614698
- 3001722928
- 3022378058
- 3011713200
- 3027339477
- 3005877899
- 3003935342
- 1225677
- 3003775006
- 3003202425
- 3004026651
- 3013944123
- 3010162973
- 3016438694
- 3004785967
- 3008632256
- 3011950073
- 3016619943
- 3012911444
- 3008253300
- 3021060474
- 2027062
- 1037955
- 3019878714
- 3011015597
- 3026391023
- 3018596740
- 3008496839
- 3017375271
- 3003477135
- 3003768277
- 2243057
- 3033525986
- 3014328942
- 3009077524
Source Documents
Other 510(k) Records For Product Code OWB
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252735 | C-beam | Pulmera, Inc. | 2026-05-22 |
| K252503 | Intelligent NR | Canon, Inc. | 2026-04-30 |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | Siemens Medical Solutions USA, Inc. | 2026-04-24 |
| K253752 | ARTIS genio floor; ARTIS icono.explore floor | Siemens Medical Solutions USA, Inc. | 2026-04-23 |
| K252229 | BELLIGER ACE | Genoray Co., Ltd. | 2026-04-02 |
| K252099 | Trinias | Shimadzu Corporation | 2026-03-24 |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Canon Medical Systems Corporation | 2026-03-10 |
| K252500 | CARA System | Cara Medical, Ltd. | 2026-02-20 |
| K251992 | ArmSure Fluoroscopic Positioning System | Savfe Co. , Ltd. | 2026-02-11 |
| K254186 | Azurion R3.1 | Philips Medical Systems B.V. | 2026-01-16 |
| K252068 | MC2 Portable X-ray System | Oxos Medical | 2025-12-22 |
| K251893 | SKAN C PULSAR | Skanray Technologies Limited | 2025-12-16 |
| K251199 | Allia Moveo | GE Medical Systems SCS | 2025-12-09 |
| K250241 | Cios Select | Siemens Medical Solutions USA, Inc. | 2025-11-04 |
| K251827 | Azurion R3.1 | Philips Medical Systems B.V. | 2025-10-24 |