FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER
K Number: K980289
·
Decision Jun 12, 1998
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
146
Applicant Total
15
Review Days
137
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Basic Information
- Device Name
- FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER
- K Number
- K980289
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1170
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Norland Corp.
- Date Received
- January 26, 1998
- Decision Date
- June 12, 1998
- 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 Norland Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K980569 | FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS | Jun 12, 1998 | Substantially Equivalent |
| K980125 | REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER | May 20, 1998 | Substantially Equivalent |
| K973459 | NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS | Feb 13, 1998 | Substantially Equivalent |
| K973104 | NORLAND MODEL PDEXA BONE DENSITOMETER | Jan 29, 1998 | Substantially Equivalent |
| K972882 | APOLLO | Oct 31, 1997 | Substantially Equivalent |
| K931996 | MODEL PDEXA BONE DENSITOMETER | Feb 1, 1995 | Substantially Equivalent |
| K926019 | FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET | Sep 23, 1994 | Substantially Equivalent |
| K922286 | MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER | Nov 27, 1992 | Substantially Equivalent |
| K913078 | LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET | Sep 24, 1991 | Substantially Equivalent |
| K901804 | NORLAND XR26 WHOLE BODY OPTION | Apr 29, 1991 | Substantially Equivalent |