FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Elekta Unity
K Number: K182076
·
Decision Dec 4, 2018
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
8
Review Days
125
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
- Elekta Unity
- K Number
- K182076
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elekta Limited
- Date Received
- August 1, 2018
- Decision Date
- December 4, 2018
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYE), ordered by most recent decision date.
ThinkQA 3
FDA 510(k)
FDA Class 2
·Radiology
LUNA 3D
FDA 510(k)
FDA Class 2
·Radiology
AerFrame Patient Immobilization System (AFPIS)
FDA 510(k)
FDA Class 2
·Radiology
VERIQA RT EPID 3D
FDA 510(k)
FDA Class 2
·Radiology
ClearCheck (RADCC V2.7)
FDA 510(k)
FDA Class 2
·Radiology
AlignRT Plus (8.0)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Elekta Limited
| K Number | Device Name | ||
|---|---|---|---|
| K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD | Jun 11, 2021 | Substantially Equivalent |
| K192482 | Elekta Unity | Dec 5, 2019 | Substantially Equivalent |
| K192242 | Synergy Platform, Synergy, Infinity, VersaHD | Nov 22, 2019 | Substantially Equivalent |
| K153011 | iViewDose R1.0 | Dec 11, 2015 | Substantially Equivalent |
| K131965 | XVI R5.0 | Sep 25, 2013 | Substantially Equivalent |
| K112613 | INTEGRITY(TM) | Dec 16, 2011 | Substantially Equivalent |
| K111676 | APEX | Sep 30, 2011 | Substantially Equivalent |