Ikshana

510(k) Number

K230249 ↗

FDA product code

LLZ

Device class

Class II

Regulation

21 CFR Part 892.2050

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

• Fluoro Plus by Advantage Medical Systems, Inc.
• Ezdenti-i E2 Prora View by Ewoosoft Co., Ltd.
• PINNACLE IMAGE PROCESSING SYSTEM by Medasys, Inc.
• Visage PACS/CS, Release Version 5.0 by Mercury Computer Systems, Inc.
• HipEOS by Onefit Medical
• SterEOS Workstation by Biospace Med
• Synapse MIP/MPR Image Visualization Software Obliquus by Fujifilm Medical System U.S.A., Inc.
• OnePacs System by Onepacs, LLC
• Kanteron Dicom Station Kds Model 3.0 by Monica Veytia
• ResolutionMD, Version 1.3 by Calgary Scientific, Inc.

• ImmersiveAR V2.0

  Class II

  FDA 510(k) K230249 Active Cleared 16 Oct 2023 GUDID on market

• ImmersiveTouch V5.0

  Class II

  FDA 510(k) K210726 Active Cleared 29 Sep 2021 GUDID on market

• ImmersiveTouch V3.0 Open recall

  Class II

  FDA 510(k) K140860 Active Cleared 16 Dec 2014 GUDID on market

• ImmersiveTouch ImmersiveTouch4 Open recall

  Class II

  FDA 510(k) K140860 Active Cleared 16 Dec 2014 GUDID on market

See all devices from ImmersiveTouch, Inc. →