FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORVUS
K Number: K201350
·
Decision Sep 20, 2020
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
5
Review Days
122
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Basic Information
- Device Name
- CORVUS
- K Number
- K201350
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Best Nomos
- Date Received
- May 21, 2020
- Decision Date
- September 20, 2020
- 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 Best Nomos
| K Number | Device Name | ||
|---|---|---|---|
| K211034 | Corvus Radiation Therapy Planning System | May 6, 2021 | Substantially Equivalent |
| K170345 | SOFTDISO | Oct 27, 2017 | Substantially Equivalent |
| K151469 | CORVUS Radiation Therapy Planning System | Nov 25, 2015 | Substantially Equivalent |
| K100092 | CORVUS RADIATION THERAPY PLANNING SYSTEM | Feb 23, 2010 | Substantially Equivalent |