FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GE DISCOVERY VCT SYSTEM
K Number: K050559
·
Decision Mar 17, 2005
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
459
Applicant Total
166
Review Days
14
Basic Information
- Device Name
- GE DISCOVERY VCT SYSTEM
- K Number
- K050559
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE MEDICAL SYSTEMS
- Date Received
- March 3, 2005
- Decision Date
- March 17, 2005
- Product Code
- KPS
- 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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | FDA class 2 | Radiology |
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|---|---|---|---|
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| 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 |
| K042694 | ADVANCED LUNG ANALYSIS II | Nov 18, 2004 | Substantially Equivalent |
| K041220 | GE DISCOVERY ST SYSTEM | Jun 15, 2004 | Substantially Equivalent |
| K040172 | MODIFICATION TO GE DISCOVERY LS SYSTEM | Apr 7, 2004 | Substantially Equivalent |
| K031637 | INNOVA 3100 | Aug 22, 2003 | Substantially Equivalent |