FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PREFERNCE IMRT TREATMENT PLANNING MODULE
K Number: K012575
·
Decision Mar 12, 2002
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
6
Review Days
215
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Basic Information
- Device Name
- PREFERNCE IMRT TREATMENT PLANNING MODULE
- K Number
- K012575
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Northwest Medical Physics Equipment, Inc.
- Date Received
- August 9, 2001
- Decision Date
- March 12, 2002
- Product Code
- MUJ
- 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 |
|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | FDA class 2 | Radiology |
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Other Clearances by Northwest Medical Physics Equipment, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063274 | ACCULOC BREAST LOCALIZATION SYSTEM | Dec 12, 2006 | Substantially Equivalent |
| K001833 | PREFERENCE TREATMENT SYSTEM | Sep 28, 2000 | 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 |