GENTUITY HF-OCT IMAGING SYSTEM

Additional Manufacturer Narrative

PULLBACKS ON (B)(6) SHOWED 8¿10 MM OF REPEATED FRAMES AT THE START OF EACH ACQUISITION. LOGS REVEALED NO ANOMALIES. AN ENGINEERING STUDY DETERMINED THIS REPEAT BUFFER IS AN INTENTIONAL DESIGN CHOICE TO ENSURE DISTAL COVERAGE. THE SYSTEM IS FUNCTIONING AS DESIGNED.

Description of Event or Problem

(B)(6) 2024: @ (B)(6) HOSPITAL. WHEN CONFIRMING THE DATA FROM THE PULLBACK DURING CLINICAL CASE USE OF (B)(6), THE IMAGE AT ABOUT 10 AT THE BEGINNING OF THE PULLBACK WAS AS IF THE LENS WAS NOT MOVING AND JUST ROTATING IN PLACE. IN TOTAL, THREE TIMES PULLBACKS WERE PERFORMED, BUT ALL IMAGES WERE IN SIMILAR CONDITION. (B)(6) 2024: @ (B)(6) HOSPITAL. (B)(6) WAS USED AGAIN IN CLINICAL CASE, AND WHEN THE DATA AFTER PULLBACK WAS CONFIRMED, THE SAME SYMPTOMS AS OF (B)(6) OCCURRED. IN TOTAL, FOUR TIMES PULLBACKS WERE PERFORMED, BUT ALL IMAGES WERE IN SIMILAR CONDITION. PLEASE LET US KNOW THE CAUSE ETC. OF THIS SYMPTOM. THE RAWDATA, ETC. HAVE BEEN SAVED IN THE FOLLOWING BOX URL, SO WE WOULD LIKE TO REQUEST CONFIRMATION IT.