FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEOPAK BMD (BONE MINERAL DENSITOMETER)
K Number: K861515
·
Decision Feb 2, 1987
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
146
Applicant Total
53
Review Days
285
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Basic Information
- Device Name
- OSTEOPAK BMD (BONE MINERAL DENSITOMETER)
- K Number
- K861515
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1170
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Siemens Gammasonics, Inc.
- Date Received
- April 23, 1986
- Decision Date
- February 2, 1987
- 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 Siemens Gammasonics, Inc.
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|---|---|---|---|
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| K933256 | FAN BEAM COLLIMATOR | Oct 29, 1993 | Substantially Equivalent |
| K920319 | SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI | Oct 20, 1992 | Substantially Equivalent |
| K923582 | SIENET CAMERA SERVER | Oct 14, 1992 | Substantially Equivalent |
| K922373 | MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM | Aug 17, 1992 | Substantially Equivalent |
| K922372 | MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM | Aug 17, 1992 | Substantially Equivalent |
| K920310 | SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE | Mar 30, 1992 | Substantially Equivalent |
| K920309 | SIENET DIAGNOSTIC REPORTING CONSOLE | Mar 20, 1992 | Substantially Equivalent |
| K914313 | HICOR | Nov 27, 1991 | Substantially Equivalent |