Envisu TM C-Class SD-OCT System

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Sherman Perry
5 years ago
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Bioptigen SDOIS is intended to acquire, process, display and save depth-resolved images of Ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT).

Imaging of the various tissues of the eye is supported through the use of interchangeable lenses.

1 Bioptigen SDOIS is intended to acquire, process, display and save depth-resolved images of Ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT). The SDOIS is indicated for use as an aid in the diagnosis of physiological and pathologic conditions of the eye through non-contact optical imaging. Imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on patient population from premature and neonatal infants to adult, and is suitable for patients ambulatory or confined. The system is indicated for use in upright or supine imaging, handheld or mounted, and is suited for imaging patients under anesthesia TM C-Class SD-OCT System This product is cleared by the FDA for the following Intended Use:

2 When to Use Bioptigen SDOCT Clinical EUA and Perioperative Remote, Field Applications Difficult Pathologies Anterior or Posterior Structures i ii iii iv

3 System is FDA Cleared...for perioperative use...for the NICU...for the Clinic...neonatal to adult...handheld or mounted

4 Yes. You can image intraoperatively. Bioptigen attached with ES-100 surgical mount for intraoperative use

5 Bioptigen attached with ES-100 surgical mount for Intraoperative use

6 CL-04-08

7 ES-100 Surgical Mount Allows for greater ease when focusing the lens Increased stability when the probe is mounted to the surgical microscope Image courtesy of Dr. Kychenthal and Dr. Dorta Clinica del Kydoft, Chile

8 ES-100 Surgical Mount

9 ES-100 Surgical Mount CL-04-08

10 Pre-op Macular Hole Image of Macular Hole diagnosed by a physician with the aid of SDOIS.

11 Post-op Macular Hole Image of Macular Hole diagnosed by a physician with the aid of SDOIS.

12 Before VM Traction Repair - top After VM Traction Repair - bottom Images of Vitreo Macular Traction diagnosed by a physician with the aid of SDOIS.

13 Corneal Surgery - before and after Provided by: Ken Nischal, MD UPMC Images diagnosed by a physician with the aid of SDOIS.

14 The only SDOCT system FDA-cleared for handheld imaging of patients from premature and neonatal infants to adults.

15 Examination Under Anesthesia Cynthia Vandenhoven, BAA, CRA The Hospital for Sick Children, Toronto, CA

16 Severe Cystoid Macular Edema of stage 4A ROP post laser Fundus Image shows vitreous condensation, traction along the superior arcade vessels Images courtesy of Dr. Jalali at the LVPEI, India Note: Laser was not done at LVPEI or by Dr. Jalali Images diagnosed by a physician with the aid of SDOIS.

17 CNVM PreAvastin 9 year old female Image of CNVM diagnosed by a physician with the aid of SDOIS.

18 Retinoblastoma Measured with Calipers Image of Retinoblastoma diagnosed by a physician with the aid of SDOIS.

19 Peters Anomaly Provided by: Julia Monsonego, and Dr. Alex Levin, Will s Eye Image of Peters Anomaly diagnosed by a physician with the aid of

20 Peters Anomaly Provided by: Julia Monsonego, and Dr. Alex Levin Image of Peters Anomaly diagnosed by a physician with the aid of SDOIS. Will s Eye

21 Yes. You can image in the NICU. Retinoblastoma Images taken by Sailaja Bondalapati and courtesy of Michelle Cabrera, M.D. University of North Carolina Images of Retinoblastoma diagnosed by a physician with the aid of SDOIS.

22 Shaken Baby Syndrome Retcam Image - OD Retcam Image -OS Images taken by Sailaja Bondalapati and courtesy of Michelle Cabrera, M.D. University of North Carolina Bioptigen OCT Bioptigen OCT Images of Shaken Baby Syndrome diagnosed by a physician with the aid of SDOIS.

23 Retinopathy of Prematurity Images taken by Denise Armiger-George, CRA, OCT-C Images of Retinopathy of Prematurity diagnosed by a physician with the aid of SDOIS.

24 Late Onset Retinal Degeneration (LORD) Clinical Setting OCT Image courtesy of NEI OCT Image taken by Denise Armiger-George, CRA, OCT-C Images of LORD diagnosed by a physician with the aid of SDOIS.

25 Bioptigen has the capability of a Retinal Scan length of 15mm Image of Normal Retina diagnosed by a physician with the aid of SDOIS.

26 Dynamic Scan Control allows for customization in real time Images of normal retina diagnosed by a physician with the aid of SDOIS.

27 CRVO - Captured in a Waiting Room in India Images taken by Denise Armiger-George, CRA, OCT-C Image of CRVO diagnosed by a physician with the aid of SDOIS.

28 Flexible Depth of the Anterior Chamber Images taken by Denise Armiger-George, CRA, OCT-C Both image diagnosis unknown by a physician with the aid of SDOIS.

29 Alström Syndrome Image taken by Denise Armiger-George, CRA, OCT-C Image diagnosis Alstrom Syndrome by a physician with the aid of SDOIS.

30 Alström Syndrome Image taken by Denise Armiger-George, CRA, OCT-C Image diagnosis Alstrom Syndrome by a physician with the aid of SDOIS.

ROP and Imaging. Deborah M Costakos MD, MS August 12, 2016

ROP and Imaging. Deborah M Costakos MD, MS August 12, 2016 ROP and Imaging Deborah M Costakos MD, MS August 12, 2016 Acknowledgements Adam Dubis, Ph.D. Joseph Carroll, Ph.D. Ryan Vogel, MD Clinton Warren, MD C Devika Subramaniam, M.D. Fouad Zakla, M.D. Alana Trotter,