510(k) K120282
- Device
- CARDNAV
- Applicant
- PAIEON, INC.
- 510(k) number
- K120282
- Product code
- OWB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-12-10
- Date received
- 2012-01-31
- 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
- SHIMON VAKNIN
- Address
- 23 Hamelacha St., P.O.B. 11355 Rosh Haayin IL 48901 48901
FDA Registration Numbers#
- 3003935342
- 9611343
- 3004754211
- 8043933
- 3019878714
- 3026391023
- 3005877899
- 1835251
- 3009001657
- 3005172103
- 2939520
- 3043048939
- 3013184485
- 3012911444
- 3005810333
- 3018077344
- 3012957335
- 3049422862
- 3015276088
- 3025394757
- 3012939903
- 3014391847
- 3033525987
- 3047842058
- 1052701
- 3027373189
- 3030412764
- 3003768277
- 3042175844
- 3014328942
- 3018094310
- 3018596740
- 3003768251
- 1720753
- 3004026651
- 3009144915
- 3015232217
- 3010703925
- 3008363989
- 3008496839
- 3014343100
- 3035950510
- 3015437189
- 3022378058
- 8030233
- 3030089787
- 9681146
- 3000126629
- 3009973505
- 3016619943
- 2243057
- 3008044777
- 2247992
- 3010462278
- 3021060474
- 3003477135
- 9614698
- 3011347852
- 3009077524
- 1037955
- 3033527282
- 3033525986
- 2027062
- 3011416394
- 1225677
- 3008284470
- 3021559833
- 3006128100
- 3010398867
- 3027339477
- 3015223550
- 3021059265
- 3004977335
- 2133772
- 3009963139
- 3012127758
- 3009196578
- 9613445
- 3011491794
- 3006544299
Source Documents#
Other 510(k) Records For Product Code OWB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253726 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | 2026-08-21 |
| K261413 | EXTRON 3;EXTRON 6 | DRTECH Corporation | 2026-08-19 |
| K254205 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2026-08-07 |
| K260607 | Shield System (Siemens 30x40) | Radiaction , Ltd. | 2026-07-31 |
| K253670 | SmartCT (R3.0 (L10)) | Philips Medical Systems B.V. | 2026-07-10 |
| 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 |
Legacy Summary#
summary
FDA Review#
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