FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUNAR IDXA
K Number: K052581
·
Decision Oct 20, 2005
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
146
Applicant Total
7
Review Days
30
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Basic Information
- Device Name
- LUNAR IDXA
- K Number
- K052581
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1170
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Medical Systems Ultrasound and Primary Care Dia
- Date Received
- September 20, 2005
- Decision Date
- October 20, 2005
- Product Code
- KGI
- 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 |
|---|---|---|---|
| KGI | Densitometer, Bone | FDA class 2 | Radiology |
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Other Clearances by Ge Medical Systems Ultrasound and Primary Care Dia
| K Number | Device Name | ||
|---|---|---|---|
| K103730 | GE LUNAR VISCERAL FAT SOFTWARE | May 6, 2011 | Substantially Equivalent |
| K072664 | GE LUNAR FEMUR STRENGTH SOFTWARE | Nov 21, 2008 | Substantially Equivalent |
| K082185 | GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 | Aug 15, 2008 | Substantially Equivalent |
| K073408 | GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 19, 2007 | Substantially Equivalent |
| K072439 | GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT | Sep 14, 2007 | Substantially Equivalent |
| K041813 | GE LOGIQ 7 ULTRASOUND BT04 | Jul 23, 2004 | Substantially Equivalent |