FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MCI OPTONIX CASSETTE OKAMOTO CASSETE
K Number: K945039
·
Decision Nov 22, 1994
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
50
Applicant Total
4
Review Days
39
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Basic Information
- Device Name
- MCI OPTONIX CASSETTE OKAMOTO CASSETE
- K Number
- K945039
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1850
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mci Optonix, Inc.
- Date Received
- October 14, 1994
- Decision Date
- November 22, 1994
- Product Code
- IXA
- 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 |
|---|---|---|---|
| IXA | Cassette, Radiographic Film | FDA class 2 | Radiology |
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