FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VORTECH'S PERSONAL DISPLAY SYSTEM
K Number: K922310
·
Decision Jul 30, 1992
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
11
Review Days
73
Basic Information
- Device Name
- VORTECH'S PERSONAL DISPLAY SYSTEM
- K Number
- K922310
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VORTECH DATA, INC.
- Date Received
- May 18, 1992
- Decision Date
- July 30, 1992
- 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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Other Clearances by VORTECH DATA, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K924366 | PERSONAL DISPLAY SYSTEM | Apr 7, 1993 | Substantially Equivalent |
| K925097 | VORTECH'S AUTOROUTER (AUTOMATIC IMAGE ROUTING) | Jan 15, 1993 | Substantially Equivalent |
| K924229 | VG-A MIG | Nov 27, 1992 | Substantially Equivalent |
| K915362 | VORTECH'S FILM DIGITIZER, FD-1 | Apr 6, 1992 | Substantially Equivalent |
| K914834 | VORTECH 3M NETWORK PRINTING | Mar 6, 1992 | Substantially Equivalent |
| K914444 | XPR PRINTER REDUNDANCY | Feb 27, 1992 | Substantially Equivalent |
| K914191 | XLP NETWORK PRINTING | Feb 18, 1992 | Substantially Equivalent |
| K915094 | VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEM | Dec 27, 1991 | Substantially Equivalent |
| K913491 | VORTECH'S PERSONAL DISPLAY SYSTEM | Sep 6, 1991 | Substantially Equivalent |
| K884434 | VORTECH'S MEDICAL IMAGING GATEWAY | Jan 19, 1989 | Substantially Equivalent |