FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MEVACHECK
K Number: K864910
·
Decision Mar 16, 1987
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
2
Review Days
91
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
- MEVACHECK
- K Number
- K864910
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Magus Microcontrollers, Inc.
- Date Received
- December 15, 1986
- Decision Date
- March 16, 1987
- 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 Magus Microcontrollers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852609 | MEVASSIST(SETUP CONTROLLER) | Feb 6, 1986 | Substantially Equivalent |