FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER
K Number: K952913
·
Decision Nov 22, 1995
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
206
Applicant Total
86
Review Days
149
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Basic Information
- Device Name
- APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER
- K Number
- K952913
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Varian Assoc., Inc.
- Date Received
- June 26, 1995
- Decision Date
- November 22, 1995
- Product Code
- JAQ
- 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 |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 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 |