GENTUITY HF-OCT IMAGING SYSTEM
Received May 28, 2026 · Event occurred Dec 12, 2024
Report 3011578544-2026-00031 · MDR key 25320788
Device
Generic name
System, Imagin, Optical Coherence Tomography (oct)
Manufacturer
Gentuity, LlcModel number
G10-01Catalog number
G10-01
Product problems
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A RECENT CONVERSATION AMONGST CLINICAL SPECIALISTS PROMPTED ME TO REVIEW EACH RUN IN THE CONSOLE FOR REPETITIVE/STACKED FRAMES AND I FOUND THAT IN 26 OF THE 28 RUNS FROM 16 CASES HERE HAD DISTAL FRAMES STACKED/FAILURE TO PULL BACK BEFORE GENERATING IMAGES.
Additional Manufacturer Narrative
REVIEW OF 16 CASES FOUND DISTAL REPEATED FRAMES IN 26 OF 28 RUNS (¿8¿10 MM). AN ENGINEERING STUDY VALIDATED THIS REPEAT BUFFER AS AN INTENTIONAL DESIGN CHOICE TO ENSURE DISTAL COVERAGE. NO SOFTWARE, HARDWARE, OR CATHETER FAILURES WERE IDENTIFIED. THE SYSTEM IS FUNCTIONING AS DESIGNED.