FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
Orfit Aerial Couchtop
K Number: K200282
·
Decision Apr 8, 2020
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
9
Review Days
64
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
- Orfit Aerial Couchtop
- K Number
- K200282
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Orfit Industries NV
- Date Received
- February 4, 2020
- Decision Date
- April 8, 2020
- Product Code
- LHN
- 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 |
|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LHN), ordered by most recent decision date.
PROBEAT-CR
FDA 510(k)
FDA Class 2
·Radiology
ProBeam 360 Proton Therapy System v3.0
FDA 510(k)
FDA Class 2
·Radiology
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
FDA 510(k)
FDA Class 2
·Radiology
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
FDA 510(k)
FDA Class 2
·Radiology
eMotus Respiratory Motion Management System
FDA 510(k)
FDA Class 2
·Radiology
P-Cure Proton Therapy System (PPTS)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Orfit Industries NV
| K Number | Device Name | ||
|---|---|---|---|
| K202068 | The AIO Solution 3.0 | Aug 14, 2020 | Substantially Equivalent |
| K191158 | The AIO Solution | Aug 6, 2019 | Substantially Equivalent |
| K171734 | HP PRO Positioning Device | Jul 25, 2017 | Substantially Equivalent |
| K162355 | Raycast MammoRx Carbon Fibre Breast Board | Nov 22, 2016 | Substantially Equivalent |
| K162862 | Raycast High Precision Lung Board Solution | Nov 9, 2016 | Substantially Equivalent |
| K151207 | Proton Immobilization Solution | Jul 28, 2015 | Substantially Equivalent |
| K141787 | SAGITTILT | Aug 7, 2014 | Substantially Equivalent |
| K131795 | NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS | Sep 26, 2013 | Substantially Equivalent |