510(k) K173639
- Device
- Luminos DRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
- Applicant
- Siemens Medical Solutions, Inc
- 510(k) number
- K173639
- Product code
- OWB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-02
- Date received
- 2017-11-24
- 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
- No
Applicant Contact#
- Contact
- Denise Adams
- Address
- 40 Liberty Blvd., 65-1a Malvern PA US 19355 19355
FDA Registration Numbers#
- 3014279513
- 3021060474
- 3019878714
- 1000181430
- 8043933
- 3035950510
- 1225677
- 3027373189
- 3010398867
- 3006128100
- 1000188474
- 3003477135
- 3027339477
- 3011713200
- 3023003446
- 2027467
- 3010703925
- 3011491794
- 3017375271
- 3009001657
- 3012631246
- 3012624817
- 3030691709
- 1056553
- 3033525987
- 3010685285
- 3005172103
- 3038614464
- 3011950073
- 2027062
- 1052701
- 3008363989
- 3008284470
- 3012911444
- 3015276088
- 9613445
- 3008496839
- 1054713
- 3012127758
- 2243057
- 3021027284
- 3036666444
- 3014328942
- 3008253300
- 3009077524
- 1723170
- 3031503890
- 1835251
- 3005843418
- 9611343
- 3009144915
- 3012957335
- 3005810333
- 3015437189
- 3004785967
- 3016619943
- 3026391023
- 3021059265
- 9681146
- 3033525986
- 3011015597
- 2939520
- 3043048939
- 1720753
- 3003202425
- 3006544299
- 3006972752
- 3013184485
- 3003768251
- 2133772
- 3025394757
- 3030089787
- 3021559833
- 1037955
- 3015223550
- 3009196578
- 3011240766
- 3002466018
- 3003775006
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 |
Legacy Summary#
summary
FDA Review#
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