FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOMOS CORVUS 5.0M
K Number: K032209
·
Decision Aug 21, 2003
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
21
Review Days
34
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
- NOMOS CORVUS 5.0M
- K Number
- K032209
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nomos Corp.
- Date Received
- July 18, 2003
- Decision Date
- August 21, 2003
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUJ), ordered by most recent decision date.
RadOncAI
FDA 510(k)
FDA Class 2
·Radiology
Multimodality Simulation Workspace (MM Sim) (v1.0.0)
FDA 510(k)
FDA Class 2
·Radiology
eXaSkin Plus
FDA 510(k)
FDA Class 2
·Radiology
ART.1-US
FDA 510(k)
FDA Class 2
·Radiology
syngo.via RT Image Suite VC10
FDA 510(k)
FDA Class 2
·Radiology
TrueFit Bolus
FDA 510(k)
FDA Class 2
·Radiology
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 |
| K013036 | NOMOS MOTORIZED CRANE II | Dec 7, 2001 | Substantially Equivalent |
| K993675 | PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM | Sep 5, 2000 | 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 |