510(k) K111505

RTVUE CAM WITH CORNEAL POWER UPGRADE by Optovue, Inc. — Product Code OBO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 8, 2011
Date Received: May 31, 2011
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Tomography, Optical Coherence
Device Class: Class II
Regulation Number: 886.1570
Review Panel: OP
Submission Type

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

Other clearances by Optovue, Inc.

K222166 — SOLIX (November 9, 2022)
K180660 — Avanti (June 8, 2018)
K163475 — iVue (June 9, 2017)
K153080 — RTVue XR OCT Avanti with AngioVue Software (February 11, 2016)
K133892 — IVUE 500 (March 19, 2014)
K130656 — IFUSION (July 3, 2013)
K121739 — IVUE WITH NORMATIVE DATABASE (January 18, 2013)
K122572 — ICAM FUNDUS CAMERA (January 11, 2013)
K120238 — RTVUE XR OCT (April 3, 2012)
K103266 — ISTAND (June 3, 2011)

Other clearances for product code OBO

K252633 — UNITY DX (UDX) (December 23, 2025)
K250553 — Tomey Cornea/Anterior Segment OCT (CASIA2) (July 18, 2025)
K250868 — SPECTRALIS HRA+OCT and variants (May 12, 2025)
K240924 — Anterion (December 13, 2024)
K241163 — SPECTRALIS with Flex Module (October 11, 2024)
K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic (July 17, 2024)
K240221 — SPECTRALIS HRA+OCT and variants (July 1, 2024)
K233933 — CIRRUS HD-OCT Model 6000 (May 17, 2024)
K233602 — P200TE (A10700) (May 9, 2024)
K233561 — 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (April 10, 2024)