FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
METRISCAN BONE DENSITY SYSTEM
K Number: K000162
·
Decision May 12, 2000
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
146
Applicant Total
6
Review Days
114
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Basic Information
- Device Name
- METRISCAN BONE DENSITY SYSTEM
- K Number
- K000162
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1170
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alara, Inc.
- Date Received
- January 19, 2000
- Decision Date
- May 12, 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 Alara, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K102479 | ALARA T210 COMPUTED RADIOGRAPHY SYSTEM | Jun 2, 2011 | Substantially Equivalent |
| K071682 | CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER) | Aug 15, 2007 | Substantially Equivalent |
| K062390 | CRYSTALVIEW R200 | Sep 18, 2006 | Substantially Equivalent |
| K061538 | ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200 | Jun 30, 2006 | Substantially Equivalent |
| K032210 | ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM | Oct 2, 2003 | Substantially Equivalent |