3DXR
GE Medical Systems SCS · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Buc
- Advisory committee description
- Radiology
- Address 1
- 283, Rue De La Miniere
- Statement or summary
- Summary
- Product code
- OWB
- Zip code
- 78530
- Applicant
- GE Medical Systems SCS
- Decision date
- 2025-02-25
- Decision code
- SESE
- Country code
- FR
- Device name
- 3DXR
- Advisory committee
- RA
- Contact
- Ning WEN
- K number
- K243446
- Date received
- 2024-11-06
- Review advisory committee
- RA
- Postal code
- 78530
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Interventional Fluoroscopic X-Ray System
- Medical specialty description
- Radiology
- Regulation number
- 892.1650
- Device class
- 2
- Registration number
- 3018094310, 3012624817, 3005172103, 3015223550, 3002672225, 3006972752, 3010703925, 3003768277, 3005706667, 3021559833, 3017375271, 3012957335, 3010398867, 2247992, 1054713, 3030412764, 3003477135, 3008284470, 3009196578, 3021060474, 3031503890, 3001722928, 3006544299, 3011015597, 3010462278, 3042175844, 3026391023, 3004977335, 3005843418, 3025394757, 3018596740, 3014343100, 3010162973, 1056553, 2031966, 3013184485, 3002466018, 3010685285, 1720753, 3027339477 +86 more
- FEI number
- 3018094310, 3012624817, 3005172103, 3015223550, 3002672225, 3006972752, 3010703925, 3005706667, 3021559833, 3017375271, 3012957335, 3010398867, 3002808382, 3030412764, 3003477135, 3008284470, 3009196578, 3021060474, 3031503890, 3000209794, 3001722928, 3006544299, 3011015597, 3010462278, 3042175844, 3026391023, 3004977335, 3002619595, 3002175190, 3005843418, 3025394757, 3018596740, 3014343100, 3013184485, 3002466018, 3010685285, 1720753, 3000205591, 1000517638, 3027339477 +86 more