FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
ONQ RTS
K Number: K123357
·
Decision Dec 28, 2012
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
4
Review Days
58
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
- ONQ RTS
- K Number
- K123357
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oncology Systems, Inc.
- Date Received
- October 31, 2012
- Decision Date
- December 28, 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 |
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