OptosAdvance 4.0 Software

510(k) Number

K162039 ↗

FDA Product Code

NFJ

FDA applicant

Optos Plc.

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Panoramic 200A

  Class II

  FDA 510(k) K042001 Active Cleared 7 Oct 2004

• PANORAMIC200 Ophthalmoscope

  Class II

  FDA 510(k) K983999 Active Cleared 3 Feb 1999

• Daytona ICG (P200TICG)

  Class II

  CE/MDR FDA 510(k) K134039 Active Cleared 11 Apr 2014

• Optos Oct/Slo Microperimeter

  Class II

  FDA 510(k) K121043 Active Cleared 22 Feb 2013

• Optos Limited Panoramic 200CAF

  Class II

  FDA 510(k) K100644 Active Cleared 15 Jul 2010

• P200MAAF

  Class II

  FDA 510(k) K102492 Active Cleared 30 Sep 2010

See all devices from Optos plc →

• What clinical setting is the OptosAdvance 4.0 Software designed for, and how does it differ from traditional retinal imaging methods?

  The OptosAdvance 4.0 Software is specifically designed for clinical radiology settings, particularly in ophthalmology, to capture wide-field retinal scans. Unlike traditional imaging techniques that often miss peripheral retinal regions, this software integrates with the Optos retinal camera to provide high-resolution images of the entire retina, including areas typically overlooked. This makes it particularly useful for diagnosing, monitoring, and documenting retinal conditions that may extend beyond the central field of view.

• Is the OptosAdvance 4.0 Software reusable or intended for single-use per session, and what are the implications for clinical workflow?

  The OptosAdvance 4.0 Software is intended for single-use per session, meaning it is not designed to be reused across multiple patients. This approach simplifies workflow by eliminating the need for reprocessing or sterilization between uses, reducing potential contamination risks. Clinicians should ensure a fresh installation or session setup for each patient to maintain optimal performance and hygiene standards.

• What hardware compatibility and IT infrastructure requirements should be considered when implementing the OptosAdvance 4.0 Software?

  The OptosAdvance 4.0 Software is a standalone digital solution that requires compatible hardware, specifically the Optos retinal camera, for operation. Beyond this, the software relies on standard IT infrastructure requirements for installation and functionality. Ensure your clinical environment meets these baseline IT needs, such as appropriate computing resources and network connectivity, to support seamless integration and performance.

• Does the OptosAdvance 4.0 Software have any specific storage or environmental conditions that must be met?

  The OptosAdvance 4.0 Software does not specify unique storage conditions beyond standard IT infrastructure requirements. This means it should be stored in a typical clinical IT environment, such as a server or workstation, following general best practices for digital systems—such as protecting against physical damage, power fluctuations, and unauthorized access—to ensure reliability and data integrity.

• What regulatory pathways has the OptosAdvance 4.0 Software undergone, and how does this affect its use in different markets?

  The OptosAdvance 4.0 Software has been authorized through the FDA’s 510(k) clearance process (K162039) and the EU’s Medical Device Regulation (MDR). This means it is legally marketable in the United States and the European Economic Area under these respective regulatory frameworks. Clinicians should confirm local compliance requirements and consult with regulatory authorities or legal advisors to ensure adherence to regional regulations when implementing the software.