FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEDIATRIC REFERENCE DATA
K Number: K001812
·
Decision Jul 10, 2000
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
146
Applicant Total
23
Review Days
25
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Basic Information
- Device Name
- PEDIATRIC REFERENCE DATA
- K Number
- K001812
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1170
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lunar Corp.
- Date Received
- June 15, 2000
- Decision Date
- July 10, 2000
- 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 Lunar Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K001756 | LUNAR REPORT GENERATOR II | Jul 6, 2000 | Substantially Equivalent |
| K000826 | PRODIGY LATERAL VIEW SOFTWARE | Apr 14, 2000 | Substantially Equivalent |
| K983564 | PRODIGY TOTAL BODY SOFTWARE | Dec 8, 1998 | Substantially Equivalent |
| K983724 | ORCA-DX BONE DENSITOMETER | Dec 8, 1998 | Substantially Equivalent |
| K983262 | FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS | Nov 18, 1998 | Substantially Equivalent |
| K983271 | FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS | Nov 18, 1998 | Substantially Equivalent |
| K983269 | FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER | Nov 18, 1998 | Substantially Equivalent |
| K982267 | DPX-RX BONE DENSITOMETER | Aug 18, 1998 | Substantially Equivalent |
| K974437 | EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE | Feb 13, 1998 | Substantially Equivalent |
| K972517 | EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE | Nov 18, 1997 | Substantially Equivalent |