FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOT-A, DOT-AR PXP-E, PXP-ER
K Number: K841905
·
Decision Aug 9, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
16
Applicant Total
53
Review Days
94
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Basic Information
- Device Name
- DOT-A, DOT-AR PXP-E, PXP-ER
- K Number
- K841905
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1310
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Siemens Gammasonics, Inc.
- Date Received
- May 7, 1984
- Decision Date
- August 9, 1984
- Product Code
- JWM
- 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 |
|---|---|---|---|
| JWM | System, Tomographic, Nuclear | FDA class 2 | 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 |