FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
K Number: K993675
·
Decision Sep 5, 2000
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
21
Review Days
309
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Basic Information
- Device Name
- PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
- K Number
- K993675
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nomos Corp.
- Date Received
- November 1, 1999
- Decision Date
- September 5, 2000
- 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 Nomos Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K070611 | BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6 | Jul 11, 2007 | Substantially Equivalent |
| K060895 | NOMOSSTAT, VERSION 1.0 | Jul 21, 2006 | Substantially Equivalent |
| K042875 | NAVIGATOR | Jul 1, 2005 | Substantially Equivalent |
| K032209 | NOMOS CORVUS 5.0M | Aug 21, 2003 | Substantially Equivalent |
| K013036 | NOMOS MOTORIZED CRANE II | Dec 7, 2001 | Substantially Equivalent |
| K993359 | RAPTOR TREATMENT PLANNING SYSTEM | Dec 21, 1999 | Substantially Equivalent |
| K991966 | THE NOMOS CHANE II | Sep 3, 1999 | Substantially Equivalent |
| K981424 | NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM | Jul 17, 1998 | Substantially Equivalent |
| K974310 | NOMOS SLIT COLLIMATOR (BEAK) | Feb 6, 1998 | Substantially Equivalent |
| K972451 | COREGISTRATION FUNCTION | Jan 22, 1998 | Substantially Equivalent |