CardIQ Suite
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
- JAK
- Zip code
- 78530
- Applicant
- GE Medical Systems SCS
- Decision date
- 2026-07-21
- Decision code
- SESE
- Country code
- FR
- Device name
- CardIQ Suite
- Advisory committee
- RA
- Contact
- Haddad Mireille
- K number
- K253770
- Date received
- 2025-11-26
- Review advisory committee
- RA
- Postal code
- 78530
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- System, X-Ray, Tomography, Computed
- Medical specialty description
- Radiology
- Regulation number
- 892.1750
- Device class
- 2
- Registration number
- 3017425975, 3004056159, 3008632256, 8022257, 3003678543, 3023003446, 3033527283, 3015223550, 3017210169, 9617978, 3027339477, 3001722928, 3013679558, 3019216, 3017426576, 1226188, 3003967489, 3023140882, 3012761544, 3006209933, 9611343, 3015777306, 3033527273, 2520313, 3002808157, 3042175844, 3008355361, 3004083736, 3010398867, 3012453401, 3039211310, 3005930550, 3042172882, 3012938564, 8043933, 3012044688, 3004753774, 3031503890, 3004977335, 3013035022 +126 more
- FEI number
- 3004056159, 3008632256, 3003678543, 3023003446, 3033527283, 3015223550, 3017210169, 3002807880, 3001726808, 3027339477, 3001722928, 3013679558, 3019216, 3017426576, 3004571294, 3003967489, 1000139922, 3023140882, 3012761544, 3006209933, 3033527273, 3015777306, 2520313, 3002808157, 3008355361, 3004083736, 3010398867, 3012453401, 3039211310, 3002619595, 3005930550, 3042172882, 1000514697, 3012938564, 3003757840, 3012044688, 3004753774, 3031503890, 3002807903, 3004977335 +126 more