FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
RAY STATION
K Number: K140187
·
Decision May 15, 2014
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
7
Review Days
111
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
- RAY STATION
- K Number
- K140187
- 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
- January 24, 2014
- Decision Date
- May 15, 2014
- 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 Raysearch Laboratories AB
| K Number | Device Name | ||
|---|---|---|---|
| K141860 | RAYSTATION | Oct 23, 2014 | Substantially Equivalent |
| K130617 | RAYSTATION | May 10, 2013 | Substantially Equivalent |
| K120387 | RAYSTATION | Apr 6, 2012 | 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 |