FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IORT SYSTEM
K Number: K933117
·
Decision Feb 16, 1995
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
6
Review Days
601
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
- IORT SYSTEM
- K Number
- K933117
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Northwest Medical Physics Center
- Date Received
- June 25, 1993
- Decision Date
- February 16, 1995
- 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 Northwest Medical Physics Center
| K Number | Device Name | ||
|---|---|---|---|
| K953227 | CASPER | Nov 22, 1995 | Substantially Equivalent |
| K941118 | HEAD IMMOBILIZATION APPARATUS | Aug 25, 1995 | Substantially Equivalent |
| K944613 | SHOULDER RETRACTOR | Jan 18, 1995 | Substantially Equivalent |
| K930182 | RADIATION TREATMENT FOR CANCER PATIENTS | Jan 5, 1994 | Substantially Equivalent |
| K904908 | STEREOTACTIC IRRADIATION SYSTEM | Jun 6, 1991 | Substantially Equivalent |