Cardiq Express Version 2.0
510(k) K073138
Cardiq Express Version 2.0 is a Class II device made by GE Medical Systems, cleared under FDA 510(k) K073138 on 26 Feb 2008, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073138 | Date26 Feb 2008 | StatusActive |
Official records
- FDA 510(k) database K073138
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JAK
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).
- SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX by Shimadzu Medical Systems
- SYNTEX SYSTEM 6000 by Syntex Corp.
- MODIFICATION TO SYNGO INSPACE 4D by Siemens Medi Cal Solutions, Inc.
- AI-Rad Companion (Musculoskeletal) 11583325 by Siemens Healthcare GmbH
- NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM by Neusoft Medical Systems Co., Ltd.
- HealthCCS by Zebra Medical Vision, Ltd.
- WHOLE BODY SCANNER by Cgr Medical Corp.
- ULTRASIM CT SYSTEM by Philips Medical Systems (Cleveland), Inc.
- TARGOBEAM by Ferguson Medical
- SOMATOM X.cite 11330001 by Siemens Healthineers AG