FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXIS Image Management System
K Number: K171098
·
Decision May 2, 2017
Classifications
1
FEI Numbers
31
Registration Numbers
32
Same Product Code
51
Applicant Total
8
Review Days
19
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Basic Information
- Device Name
- AXIS Image Management System
- K Number
- K171098
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sonomed, Inc.
- Date Received
- April 13, 2017
- Decision Date
- May 2, 2017
- Product Code
- NFJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- OP
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NFJ | System, Image Management, Ophthalmic | FDA class 2 | Radiology |
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| K040668 | E-Z SCAN AB5500+ | Apr 13, 2004 | Substantially Equivalent |
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