FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISITRAK, VERSION 1, RELEASE 1
K Number: K050372
·
Decision Mar 25, 2005
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
7
Review Days
39
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
- VISITRAK, VERSION 1, RELEASE 1
- K Number
- K050372
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Math Resolutions, LLC
- Date Received
- February 14, 2005
- Decision Date
- March 25, 2005
- 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 Math Resolutions, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K162577 | Dosimetry Check Version 5 Release 1 | Nov 18, 2016 | Substantially Equivalent |
| K132605 | DOSIMETRY CHECK VERSION 4 RELEASE 1 | Nov 14, 2013 | Substantially Equivalent |
| K101503 | DUSIMETRY CHECK | Aug 4, 2010 | Substantially Equivalent |
| K022961 | RTDOSEPLAN | Jan 31, 2003 | Substantially Equivalent |
| K011845 | MILLCOMP | Dec 4, 2001 | Substantially Equivalent |
| K010225 | DOSIMETRY CHECK | Apr 24, 2001 | Substantially Equivalent |