FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIQ EXPRESS VERSION 2.0
K Number: K073138
·
Decision Feb 26, 2008
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
169
Review Days
111
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CARDIQ EXPRESS VERSION 2.0
- K Number
- K073138
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE Medical Systems
- Date Received
- November 7, 2007
- Decision Date
- February 26, 2008
- Product Code
- JAK
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAK), ordered by most recent decision date.
Respiratory Gating for Scanners (2.1)
FDA 510(k)
FDA Class 2
·Radiology
Aquilion ONE (TSX-308A/TSX-306A) V2.0
FDA 510(k)
FDA Class 2
·Radiology
Spectral CT Verida Family
FDA 510(k)
FDA Class 2
·Radiology
True Definition DL
FDA 510(k)
FDA Class 2
·Radiology
CT Rembra RT; CT Areta RT; CT Rembra
FDA 510(k)
FDA Class 2
·Radiology
SOMATOM X.cite; SOMATOM X.ceed
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by GE Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K220851 | Venue | Jun 27, 2022 | Substantially Equivalent |
| K220848 | Venue Fit | Jun 27, 2022 | Substantially Equivalent |
| K173341 | Vivid E80, Vivid E90, Vivid E95 | Nov 2, 2017 | Substantially Equivalent |
| K103411 | IDEAL IQ SOFTWARE OPTION | Mar 22, 2011 | Substantially Equivalent |
| K053009 | GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM | Nov 17, 2005 | Substantially Equivalent |
| K052434 | HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA | Sep 27, 2005 | Substantially Equivalent |
| K051673 | XELERIS 2 PROCESSING AND REVIEW WORKSTATION | Jul 18, 2005 | Substantially Equivalent |
| K051449 | GE VIVID 7 WITH OR WITHOUT SUFFIX | Jun 16, 2005 | Substantially Equivalent |
| K050559 | GE DISCOVERY VCT SYSTEM | Mar 17, 2005 | Substantially Equivalent |
| K042694 | ADVANCED LUNG ANALYSIS II | Nov 18, 2004 | Substantially Equivalent |