FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
OptosAdvance 4.0 Software
K Number: K162039
·
Decision Feb 8, 2017
Classifications
1
FEI Numbers
31
Registration Numbers
32
Same Product Code
51
Applicant Total
15
Review Days
201
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OptosAdvance 4.0 Software
- K Number
- K162039
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Optos Plc.
- Date Received
- July 22, 2016
- Decision Date
- February 8, 2017
- Product Code
- NFJ
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| NFJ | System, Image Management, Ophthalmic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NFJ), ordered by most recent decision date.
Harmony Referral System with Harmony OCT Viewer (Octave)
FDA 510(k)
FDA Class 2
·Radiology
iCare ALTIUS CW
FDA 510(k)
FDA Class 2
·Radiology
IMAGEnet6 Ophthalmic Data System
FDA 510(k)
FDA Class 2
·Radiology
CALLISTO eye
FDA 510(k)
FDA Class 2
·Radiology
Harmony
FDA 510(k)
FDA Class 2
·Radiology
CALLISTO eye
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Optos Plc.
| K Number | Device Name | ||
|---|---|---|---|
| K233602 | P200TE (A10700) | May 9, 2024 | Substantially Equivalent |
| K231673 | P200TE (A10700) | Aug 18, 2023 | Substantially Equivalent |
| K190732 | P200TxE | Jul 31, 2019 | Substantially Equivalent |
| K173707 | P200TE | Feb 28, 2018 | Substantially Equivalent |
| K142897 | P200DTx | Jan 16, 2015 | Substantially Equivalent |
| K134039 | DAYTONA ICG (P200TICG) | Apr 11, 2014 | Substantially Equivalent |
| K121043 | OPTOS OCT/SLO MICROPERIMETER | Feb 22, 2013 | Substantially Equivalent |
| K113696 | OPTOS ADVANCE | May 25, 2012 | Substantially Equivalent |
| K111628 | P200T | Aug 19, 2011 | Substantially Equivalent |
| K102492 | P200MAAF | Sep 30, 2010 | Substantially Equivalent |