FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXT 1400 SPOTFILM DEVICE
K Number: K942367
·
Decision Jun 6, 1994
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
12
Applicant Total
3
Review Days
19
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Basic Information
- Device Name
- AXT 1400 SPOTFILM DEVICE
- K Number
- K942367
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1670
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Applied X-Ray Technologies, Inc.
- Date Received
- May 18, 1994
- Decision Date
- June 6, 1994
- Product Code
- IXL
- 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 |
|---|---|---|---|
| IXL | Device, Spot-Film | FDA class 2 | Radiology |
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