FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LINAC-BASED STEROTACTIC RADIOSURGERY
K Number: K923522
·
Decision Aug 18, 1993
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
12
Review Days
398
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
- LINAC-BASED STEROTACTIC RADIOSURGERY
- K Number
- K923522
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radionics Software Applications, Inc.
- Date Received
- July 16, 1992
- Decision Date
- August 18, 1993
- 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 Software Applications, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990326 | OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII | Mar 4, 1999 | Substantially Equivalent |
| K974602 | OPTICAL TRACKING SYSTEM (OTS) | Apr 21, 1998 | Substantially Equivalent |
| K972905 | XPLAN-1 | Oct 28, 1997 | Substantially Equivalent |
| K964801 | OPTICAL TRACKING SYSTEM (OTS) | Jun 2, 1997 | Substantially Equivalent |
| K961844 | OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] | Oct 23, 1996 | Substantially Equivalent |
| K962155 | GILL-THOMAS-COSMAN(GTC) DENTAL TRAY | Aug 22, 1996 | Substantially Equivalent |
| K960071 | IMAGEFUSION | Apr 17, 1996 | Substantially Equivalent |
| K951262 | OPERATING ARM SYSTEM (OAS) | Nov 13, 1995 | Substantially Equivalent |
| K944463 | CRW-1 SYSTEM | Oct 26, 1995 | Substantially Equivalent |
| K953482 | XKNIFE-3 | Oct 25, 1995 | Substantially Equivalent |