FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Axialis Ophthalmic Ultrasound System
K Number: K213254
·
Decision Nov 15, 2021
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
30
Review Days
46
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Basic Information
- Device Name
- Axialis Ophthalmic Ultrasound System
- K Number
- K213254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quantel Medical
- Date Received
- September 30, 2021
- Decision Date
- November 15, 2021
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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