FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM
K Number: K912180
·
Decision Oct 21, 1991
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
16
Applicant Total
24
Review Days
158
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Basic Information
- Device Name
- MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM
- K Number
- K912180
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1610
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Instrumentarium Imaging, Inc.
- Date Received
- May 16, 1991
- Decision Date
- October 21, 1991
- Product Code
- IZX
- 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 |
|---|---|---|---|
| IZX | Collimator, Manual, Radiographic | FDA class 2 | Radiology |
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