FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXT 150M MANUAL COLLIMATOR (AXT 150M)
K Number: K972966
·
Decision Aug 21, 1997
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
16
Applicant Total
3
Review Days
10
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Basic Information
- Device Name
- AXT 150M MANUAL COLLIMATOR (AXT 150M)
- K Number
- K972966
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1610
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Applied X-Ray Technologies, Inc.
- Date Received
- August 11, 1997
- Decision Date
- August 21, 1997
- 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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