FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PREFERENCE TREATMENT SYSTEM
K Number: K001833
·
Decision Sep 28, 2000
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
6
Review Days
104
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
- PREFERENCE TREATMENT SYSTEM
- K Number
- K001833
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Northwest Medical Physics Equipment, Inc.
- Date Received
- June 16, 2000
- Decision Date
- September 28, 2000
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYE), ordered by most recent decision date.
ThinkQA 3
FDA 510(k)
FDA Class 2
·Radiology
LUNA 3D
FDA 510(k)
FDA Class 2
·Radiology
AerFrame Patient Immobilization System (AFPIS)
FDA 510(k)
FDA Class 2
·Radiology
VERIQA RT EPID 3D
FDA 510(k)
FDA Class 2
·Radiology
ClearCheck (RADCC V2.7)
FDA 510(k)
FDA Class 2
·Radiology
AlignRT Plus (8.0)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Northwest Medical Physics Equipment, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063274 | ACCULOC BREAST LOCALIZATION SYSTEM | Dec 12, 2006 | Substantially Equivalent |
| K012575 | PREFERNCE IMRT TREATMENT PLANNING MODULE | Mar 12, 2002 | Substantially Equivalent |
| K983793 | PREFERENCE TREATMENT SYSTEM | Oct 5, 1999 | Substantially Equivalent |
| K970464 | P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1 | Sep 5, 1997 | Substantially Equivalent |
| K960293 | MRTOFLM COMPUTER PROGRAM | Aug 1, 1996 | Substantially Equivalent |