FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VISIONLINK ACR-NEMA CONVERSION UTILITIES
K Number: K935103
·
Decision Feb 9, 1994
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
7
Review Days
107
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Basic Information
- Device Name
- VISIONLINK ACR-NEMA CONVERSION UTILITIES
- K Number
- K935103
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Evergreen Technologies, Inc.
- Date Received
- October 25, 1993
- Decision Date
- February 9, 1994
- Product Code
- LMD
- 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 |
|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | FDA class 1 | 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 |
| 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 |
| K921484 | MEDVISION | Aug 7, 1992 | Substantially Equivalent |