FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED CASS SYSTEM
K Number: K902488
·
Decision Dec 7, 1990
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
6
Review Days
191
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
- MODIFIED CASS SYSTEM
- K Number
- K902488
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Medical Instrumentation & Diagnostics Corp.(Midco)
- Date Received
- May 30, 1990
- Decision Date
- December 7, 1990
- Product Code
- KXK
- 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 |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KXK), ordered by most recent decision date.
OncoPatch
FDA 510(k)
FDA Class 2
·Radiology
IsoSphere
FDA 510(k)
FDA Class 2
·Radiology
RadianceTx Radionuclide Brachytherapy Source
FDA 510(k)
FDA Class 2
·Radiology
GammaTile
FDA 510(k)
FDA Class 2
·Radiology
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
FDA 510(k)
FDA Class 2
·Radiology
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
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 |
| K961484 | CASS SYSTEM (MODIFICATION) | Nov 7, 1996 | 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 |
| K894263 | CASS SYSTEM | Sep 1, 1989 | Substantially Equivalent |