FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CASS SYSTEM (MODIFICATION)
K Number: K961484
·
Decision Nov 7, 1996
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
6
Review Days
223
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
- CASS SYSTEM (MODIFICATION)
- K Number
- K961484
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Instrumentation & Diagnostics Corp.(Midco)
- Date Received
- March 29, 1996
- Decision Date
- November 7, 1996
- 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 Medical Instrumentation & Diagnostics Corp.(Midco)
| K Number | Device Name | ||
|---|---|---|---|
| K991336 | BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY | Jul 12, 1999 | Substantially Equivalent |
| K921740 | COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED | Apr 7, 1993 | Substantially Equivalent |
| K911750 | COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED | Oct 15, 1991 | Substantially Equivalent |
| K902488 | MODIFIED CASS SYSTEM | Dec 7, 1990 | Substantially Equivalent |
| K894263 | CASS SYSTEM | Sep 1, 1989 | Substantially Equivalent |