FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
RAYSTATION
K Number: K120387
·
Decision Apr 6, 2012
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
7
Review Days
59
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Basic Information
- Device Name
- RAYSTATION
- K Number
- K120387
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Raysearch Laboratories AB
- Date Received
- February 7, 2012
- Decision Date
- April 6, 2012
- 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 Raysearch Laboratories AB
| K Number | Device Name | ||
|---|---|---|---|
| K141860 | RAYSTATION | Oct 23, 2014 | Substantially Equivalent |
| K140187 | RAY STATION | May 15, 2014 | Substantially Equivalent |
| K130617 | RAYSTATION | May 10, 2013 | Substantially Equivalent |
| K100552 | RAYSTATION VERSION 1.0 | Mar 12, 2010 | Substantially Equivalent |
| K083264 | RAYAUTOPLAN 1.0 | Jan 22, 2009 | Substantially Equivalent |
| K082221 | RAYDOSE | Oct 22, 2008 | Substantially Equivalent |