FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BODYSCAN
K Number: K870818
·
Decision Mar 16, 1987
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
53
Review Days
13
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Basic Information
- Device Name
- BODYSCAN
- K Number
- K870818
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Siemens Gammasonics, Inc.
- Date Received
- March 3, 1987
- Decision Date
- March 16, 1987
- Product Code
- IYX
- 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 |
|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | FDA class 1 | Radiology |
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Other Clearances by Siemens Gammasonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934766 | CARBON FIBER PALLET | Feb 18, 1994 | Substantially Equivalent |
| K933664 | POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) | Dec 15, 1993 | Substantially Equivalent |
| 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 |