Product Classification

• Device: tomography, optical coherence
• Regulation Description: Ophthalmoscope.
• Definition: Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
• Physical State: Computerized imaging device consisting of light sources and beam delivery and scanning optics.
• Technical Method: Cross sectional tomograms of ocular structures are obtained using non-invasive, non-contact, low-coherence optical interferometry.
• Target Area: Eye.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: OBO
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Ophthalmic Devices (DHT1A)
• Submission Type: 510(k)
• Regulation Number: 886.1570
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 10-123 ISO 15004-1 Second edition 2020-5
  Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
• 10-138 ISO 16971-1 First edition 2024-11
  Ophthalmic instruments - Optical coherence tomographs - Part 1: Optical coherence tomographs for the posterior segment of the human eye
• 12-352 NEMA PS 3.1 - 3.20 2023e
  Digital Imaging and Communications in Medicine (DICOM) Set
• 12-363 NEMA PS 3.1 - 3.20 2024e
  Digital Imaging and Communications in Medicine (DICOM) Set

Third Party Review

Not Third Party Eligible