FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIEMENS PACS/1-B (OPTICAL DISK OPTION)
K Number: K884995
·
Decision Feb 28, 1989
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
53
Review Days
89
Basic Information
- Device Name
- SIEMENS PACS/1-B (OPTICAL DISK OPTION)
- K Number
- K884995
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- SIEMENS GAMMASONICS, INC.
- Date Received
- December 1, 1988
- Decision Date
- February 28, 1989
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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| 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 |
| K922372 | MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM | Aug 17, 1992 | Substantially Equivalent |
| K922373 | MULTISPECT(TM) 2 DUAL 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 |