FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIONICS VARILINK 2
K Number: K023519
·
Decision Jan 16, 2003
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
8
Review Days
87
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
- RADIONICS VARILINK 2
- K Number
- K023519
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radionics, A Division of Tyco Healthcare Group LP
- Date Received
- October 21, 2002
- Decision Date
- January 16, 2003
- 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 Radionics, A Division of Tyco Healthcare Group LP
| K Number | Device Name | ||
|---|---|---|---|
| K051947 | RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE | Aug 22, 2005 | Substantially Equivalent |
| K041997 | RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE | Aug 27, 2004 | Substantially Equivalent |
| K032054 | RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE | Sep 15, 2003 | Substantially Equivalent |
| K021942 | RADIONICS POLE NEEDLES | Sep 11, 2002 | Substantially Equivalent |
| K013661 | XPLAN 2.2 WITH THE BODY SYSTEM | Dec 3, 2001 | Substantially Equivalent |
| K012850 | RECORDING AND STIMULATING ELECTRODE | Nov 19, 2001 | Substantially Equivalent |
| K010548 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | Mar 12, 2001 | Substantially Equivalent |