510(k) K061163
- Device
- INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT
- Applicant
- GE MEDICAL SYSTEMS, LLC
- 510(k) number
- K061163
- Product code
- OWB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-06-07
- Date received
- 2006-04-26
- 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
- LARRY A KROGER
- Address
- 3000 N. Grandview Blvd. Waukesha WI US 53188 53188
FDA Registration Numbers#
- 3005706667
- 3003768277
- 3015232217
- 3015223550
- 9613445
- 3003775006
- 3025394757
- 3009715136
- 9611343
- 3021027284
- 3000126629
- 3012127758
- 3016438694
- 3030412764
- 1225677
- 1054713
- 3003477135
- 3022378058
- 3010162973
- 3036666444
- 3008044777
- 1000188474
- 3021059265
- 1000181430
- 3014343100
- 3002466018
- 2031966
- 3030691709
- 3017375271
- 3012911444
- 3011713200
- 9614698
- 3012624817
- 3001722928
- 3006128100
- 1052701
- 3003768251
- 3009001657
- 1720753
- 3004198450
- 3008632256
- 3026391023
- 3012939903
- 3018077344
- 3008363989
- 3021559833
- 3006544299
- 3010398867
- 2027467
- 2247992
- 3030089787
- 3013944123
- 3010703925
- 2027062
- 3005877899
- 3023003446
- 3043048939
- 3042175844
- 3004785967
- 3018596740
- 3011347852
- 3027339477
- 3008496839
- 3038614464
- 3009196578
- 3014391847
- 1835251
- 3013184485
- 2939520
- 1037955
- 3012631246
- 3011240766
- 3033525986
- 3011015597
- 3033527770
- 3014279513
- 3009963139
- 3019878714
- 3027373189
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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