FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GE DISCOVERY LS SYSTEM
K Number: K023988
·
Decision Feb 4, 2003
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
169
Review Days
64
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Basic Information
- Device Name
- GE DISCOVERY LS SYSTEM
- K Number
- K023988
- 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
- December 2, 2002
- Decision Date
- February 4, 2003
- Product Code
- KPS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
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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| 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 |