FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QFIX RADIOTHERAPY CHAIR
K Number: K120916
·
Decision Jun 20, 2012
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
31
Applicant Total
8
Review Days
85
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- QFIX RADIOTHERAPY CHAIR
- K Number
- K120916
- 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 27, 2012
- Decision Date
- June 20, 2012
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAI), ordered by most recent decision date.
Eve Patient Positioner System
FDA 510(k)
FDA Class 2
·Radiology
Z-Robot Patient Positioning System
FDA 510(k)
FDA Class 2
·Radiology
Patient Positioning System
FDA 510(k)
FDA Class 2
·Radiology
LEONI ORION System
FDA 510(k)
FDA Class 2
·Radiology
PROTURA COUCH SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
PATIENT POSITIONING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Wfr/Aquaplast Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K060671 | KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS | May 4, 2006 | 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 |