FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Avanti
K Number: K180660
·
Decision Jun 8, 2018
Classifications
1
FEI Numbers
29
Registration Numbers
30
Same Product Code
65
Applicant Total
16
Review Days
86
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Basic Information
- Device Name
- Avanti
- K Number
- K180660
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Optovue, Inc.
- Date Received
- March 14, 2018
- Decision Date
- June 8, 2018
- Product Code
- OBO
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| OBO | Tomography, Optical Coherence | FDA class 2 | Ophthalmic |
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|---|---|---|---|
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| K153080 | RTVue XR OCT Avanti with AngioVue Software | Feb 11, 2016 | Substantially Equivalent |
| K133892 | IVUE 500 | Mar 19, 2014 | Substantially Equivalent |
| K130656 | IFUSION | Jul 3, 2013 | Substantially Equivalent |
| K121739 | IVUE WITH NORMATIVE DATABASE | Jan 18, 2013 | Substantially Equivalent |
| K122572 | ICAM FUNDUS CAMERA | Jan 11, 2013 | Substantially Equivalent |
| K120238 | RTVUE XR OCT | Apr 3, 2012 | Substantially Equivalent |
| K111505 | RTVUE CAM WITH CORNEAL POWER UPGRADE | Sep 8, 2011 | Substantially Equivalent |
| K103266 | ISTAND | Jun 3, 2011 | Substantially Equivalent |