Radiology · 510(k) · 2018
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
NinePoint Medical, Inc.. Cleared by FDA on 2 November 2018 under submission K182616, product code NQQ (system, imaging, optical coherence tomography (oct)). What FDA's record says, in FDA's words.
Device record · K182616
- Device. NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemDEVICE
- Company. NinePoint Medical, Inc.COMPANY
- Decision. 2 November 2018, 510(k), unknown (traditional review); received 21 September 2018DECISION
- Panel. RadiologyPANEL
- Product code. NQQ, System, Imaging, Optical Coherence Tomography (Oct)CODE
- Regulation. 21 CFR 892.1560, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
“The NvisionVLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensiona l, cross-sectional, real-time depth visualization and may be used to mark areas of tissue. The software provides segmentation and display of common imaging features, including hyper- reflective surface, layering, and hypo-reflective structures.” must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotiona l materials, in close proximity to the trade name, of a similar point size, and in bold print. Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a
The product code's definition, from FDA's classification record. This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 69 reports filed against devices carrying product code NQQ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
12 June 2026 · Malfunction · G10-01 GENTUITY HF-OCT IMAGING SYSTEM · GENTUITY, LLC · report 3011578544-2026-00054
ON14 FEB 2023: (B)(6) HEAD OFFICE: ON (B)(6) 2023 AFTER UPGRADING S/N: (B)(6) (V21.11.7 V21.11.9) AND THE BIOS UPDATE WORK, "CRITICALERROR" OCCURRED WHEN STARTING THE CONSOLE AND LOGGING INTO THE SERVICE BACKDOOR. UPON REBOOTING AFTER SHUTDOWN, THE MESSAGE DISPLAYED "THERE WAS AN ERROR STARTING THE SYSTEM. PLEASE CONTACT GENTUITY IF THE PROBLEM PERSISTS." AFTER THAT, REPEATED MANY TIMES RESTARTS, BUT SAME MESSAGE DISPLAYED ALL. "THERE WAS AN ERROR STARTING THE SYSTEM. PLEASE CONTACT GENTUITY […]
12 June 2026 · Malfunction · G30-01 VIS-RX MICRO-IMAGING CATHETER · GENTUITY, LLC · report 3011578544-2026-00056
BOTH DOCTORS (B)(6) AT (B)(6) SAID THAT THEY ARE CONCERNED ABOUT THE ACCURACY OF THE LENGTH OF OUR SYSTEM. DR (B)(6) SAID THAT "THEY (THE GROUP) ARE ALL TALKING ABOUT IT, AND THEY DON'T BELIEVE IT." WHEN I DID A CASE WITH DR (B)(6) HE PLACED A 23 MM ABBOTT STENT, AND WHEN I MEASURED IT, THE SYSTEM MEASURED 27 MM. SO I WENT BACK AND LOOKED AT DOCTOR (B)(6) CASE FROM THE DAY PRIOR, AND THAT WAS A 26 MM BIOTRONIC STENT, AND IT MEASURED 26 MM EXACTLY. (I DID NOT GET THE OPPORTUNITY TO SHARE THIS […]
1 June 2026 · Malfunction · GENTUITY HF-OCT IMAGING SYSTEM · GENTUITY, LLC · report 3011578544-2026-00040
DR. (B)(6), PART A PA STUDY: THE FIRST ATTEMPT OF AN ACQUISITION TIME OUT ON CALIBRATION AND THE STAFF TRIED IT A SECOND TIME WITH A SUCCESSFUL IMAGE ACQUIRED. NO INTERVENTION WAS PERFORMED, SO THE CASE WAS ENDED. POST PROCEDURE, (B)(6), (RESEARCH COORDINATOR) ATTEMPTED TO RELEASE THE VIS RX CATHETER FROM THE PIM AND THE PULLBACK PORTION OF THE CATHETER WOULD NOT RELEASE. (B)(6) CALLED ME AGAIN ON WHATSAPP VIDEO CHAT AND I TALKED HER THROUGH TROUBLE SHOOTING WITH NO SUCCESS. I ASKED HER TO […]
28 May 2026 · Malfunction · GENTUITY HF-OCT IMAGING SYSTEM · GENTUITY, LLC · report 3011578544-2026-00031
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.
27 May 2026 · Malfunction · GENTUITY HF-OCT IMAGING SYSTEM · GENTUITY, LLC · report 3011578544-2026-00027
WHILE DOING A CASE WITH DR (B)(6) YESTERDAY, HE WAS VERY UNHAPPY WITH THE LONGITUDINAL MEASUREMENTS. HE DID NOT BELIEVE THE PRE (WHICH I MEASURED AT 26 MM, AND HE THOUGHT IT REALLY SHOULD BE 28 OR EVEN 30MM). EVEN TO THE POINT THAT HE WANTED TO DISCUSS AFTER THE CASE. (IT WAS TOWARDS THE DISTAL END OF THE RUN). THE POST STENT MEASUREMENTS WERE OFF ALSO, WHICH I DID NOT BRING TO HIS ATTENTION. HE HAD PLACED A 28MM ABBOTT STENT, AND IT MEASURED 31MM. BOTH OCT RUNS AND LOGS WERE UPLOADED TO BOX.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code NQQ, in Radiology, or cleared in 2018. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.