FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION
K Number: K942120
·
Decision Jul 18, 1994
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
195
Applicant Total
166
Review Days
76
Basic Information
- Device Name
- ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION
- K Number
- K942120
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE MEDICAL SYSTEMS
- Date Received
- May 3, 1994
- Decision Date
- July 18, 1994
- Product Code
- IZI
- 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 |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZI), ordered by most recent decision date.
Affirm 800
FDA 510(k)
FDA Class 2
·Radiology
Modus IR
FDA 510(k)
FDA Class 2
·Radiology
EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
FDA 510(k)
FDA Class 2
·Radiology
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
FDA 510(k)
FDA Class 2
·Radiology
SPY Portable Handheld Imaging (SPY-PHI) System
FDA 510(k)
FDA Class 2
·Radiology
EXPLORER AIR® II
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by GE MEDICAL SYSTEMS
| K Number | Device Name | ||
|---|---|---|---|
| K103411 | IDEAL IQ SOFTWARE OPTION | Mar 22, 2011 | Substantially Equivalent |
| K073138 | CARDIQ EXPRESS VERSION 2.0 | Feb 26, 2008 | 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 |
| K041220 | GE DISCOVERY ST SYSTEM | Jun 15, 2004 | Substantially Equivalent |
| K040172 | MODIFICATION TO GE DISCOVERY LS SYSTEM | Apr 7, 2004 | Substantially Equivalent |