FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110
K Number: K910308
·
Decision Mar 27, 1991
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
39
Applicant Total
4
Review Days
62
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
- X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110
- K Number
- K910308
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1760
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Inmark Corp.
- Date Received
- January 24, 1991
- Decision Date
- March 27, 1991
- Product Code
- ITY
- 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 |
|---|---|---|---|
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITY), ordered by most recent decision date.
X-RAY MONOBLOCK, MONOBLOCK XRS-60-330
FDA 510(k)
FDA Class 1
·Radiology
MRX-750
FDA 510(k)
FDA Class 1
·Radiology
MOLYBDENUM
FDA 510(k)
FDA Class 1
·Radiology
PHILIPS PRE-FILTER OPTION
FDA 510(k)
FDA Class 1
·Radiology
MRX-700
FDA 510(k)
FDA Class 1
·Radiology
MRX-865
FDA 510(k)
FDA Class 1
·Radiology