OptosAdvance 4.0 Software
FDA 510(k) K162039 · Optos Plc.
510(k) numberK162039
Submission
- Device name
- OptosAdvance 4.0 Software
- Applicant
- Optos Plc.
Dunfermline, GB - Received
- July 22, 2016
- Decision date
- February 8, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was OptosAdvance 4.0 Software cleared by the FDA?
OptosAdvance 4.0 Software (K162039) received a 510(k) decision of Substantially Equivalent on February 8, 2017, 201 days after the submission was received.
What is the product code of K162039?
The FDA product code is NFJ – System, Image Management, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 892.2050.