FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDVISION
K Number: K921484
·
Decision Aug 7, 1992
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
7
Review Days
130
Basic Information
- Device Name
- MEDVISION
- K Number
- K921484
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- EVERGREEN TECHNOLOGIES, INC.
- Date Received
- March 30, 1992
- Decision Date
- August 7, 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 EVERGREEN TECHNOLOGIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K942861 | MEDVISION ENVIROMENT/MEDVISION 2.0 | Dec 7, 1994 | Substantially Equivalent |
| K942860 | VISIONLINK DICOM MODULE | Sep 16, 1994 | Substantially Equivalent |
| K935103 | VISIONLINK ACR-NEMA CONVERSION UTILITIES | Feb 9, 1994 | Substantially Equivalent |
| K933372 | VISIONLINK INTERFILE CONVERSION SOFTWARE | Nov 1, 1993 | Substantially Equivalent |
| K933209 | VISIONTOOL | Sep 29, 1993 | Substantially Equivalent |
| K924178 | MEDVISION(TM) IMAGING SOFTWARE | Feb 2, 1993 | Substantially Equivalent |