FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS
K Number: K060671
·
Decision May 4, 2006
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
31
Applicant Total
8
Review Days
51
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Basic Information
- Device Name
- KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS
- K Number
- K060671
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wfr/Aquaplast Corp.
- Date Received
- March 14, 2006
- Decision Date
- May 4, 2006
- Product Code
- JAI
- 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 |
|---|---|---|---|
| JAI | Couch, Radiation Therapy, Powered | FDA class 2 | Radiology |
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Other Clearances by Wfr/Aquaplast Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K120916 | QFIX RADIOTHERAPY CHAIR | Jun 20, 2012 | Substantially Equivalent |
| K032156 | ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT | Sep 2, 2003 | Substantially Equivalent |
| K021124 | ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER | Jul 2, 2002 | Substantially Equivalent |
| K973370 | AQUAPLAST PALATAL STENT | Dec 2, 1997 | Substantially Equivalent |
| K943871 | AQUAPLAST TIE DOWN DRESSING | Sep 30, 1994 | Substantially Equivalent |
| K942158 | AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS | Jul 29, 1994 | Substantially Equivalent |
| K935067 | AQUAPLAST | May 26, 1994 | Substantially Equivalent |