FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
RAYAUTOPLAN 1.0
K Number: K083264
·
Decision Jan 22, 2009
Classifications
1
FEI Numbers
50
Registration Numbers
51
Same Product Code
243
Applicant Total
7
Review Days
78
Basic Information
- Device Name
- RAYAUTOPLAN 1.0
- K Number
- K083264
- 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
- November 5, 2008
- Decision Date
- January 22, 2009
- Product Code
- MUJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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.
RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT
FDA 510(k)
FDA Class 2
·Radiology
RayCare (2024A SP1)
FDA 510(k)
FDA Class 2
·Radiology
Oncospace
FDA 510(k)
FDA Class 2
·Radiology
RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
FDA 510(k)
FDA Class 2
·Radiology
ART-Plan+ (v.3.0.0)
FDA 510(k)
FDA Class 2
·Radiology
ARIA Radiation Therapy Management System (18.1)
FDA 510(k)
FDA Class 2
·Radiology
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 |
| K120387 | RAYSTATION | Apr 6, 2012 | Substantially Equivalent |
| K100552 | RAYSTATION VERSION 1.0 | Mar 12, 2010 | Substantially Equivalent |
| K082221 | RAYDOSE | Oct 22, 2008 | Substantially Equivalent |