FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION
K Number: K952313
·
Decision Aug 16, 1995
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
86
Review Days
91
Basic Information
- Device Name
- VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION
- K Number
- K952313
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VARIAN ASSOC., INC.
- Date Received
- May 17, 1995
- Decision Date
- August 16, 1995
- 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 VARIAN ASSOC., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K000922 | PROTON VISION | May 24, 2000 | Substantially Equivalent |
| K992762 | BRACHYVISION 6.0 | Mar 9, 2000 | Substantially Equivalent |
| K992751 | SOMAVISION | Feb 16, 2000 | Substantially Equivalent |
| K992753 | CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM | Sep 3, 1999 | Substantially Equivalent |
| K990085 | MILLENNIUM MLC -120 | Feb 8, 1999 | Substantially Equivalent |
| K980601 | VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER | Oct 21, 1998 | Substantially Equivalent |
| K955844 | APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER | Jul 26, 1996 | Substantially Equivalent |
| K955774 | VARIS PORTALVISION | Mar 15, 1996 | Substantially Equivalent |
| K954467 | CADPLAN BT | Mar 15, 1996 | Substantially Equivalent |
| K943224 | VARIAN MULTILEAF COLLIMATOR | Feb 2, 1996 | Substantially Equivalent |