Is this your brand? Sign in to claim ownership.

NINEPOINT MEDICAL, INC.

Last updated May 30, 2026

What NINEPOINT MEDICAL, INC. makes

The company manufactures endoscopic optical coherence tomography (OCT) systems, including imaging probes and consoles for visualising internal tissue structures. These systems are paired with single-use catheter/overtube balloon inflators and marking probes designed for targeted biopsy procedures. The portfolio includes probes of varying sizes and working distances, as well as upgradeable imaging systems and refurbished consoles.

The devices fall under Class II regulatory classification in the US and are listed in the FDA’s 510(k) and UDI registries. The company is based in the United States, where these products are authorised for commercial distribution.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Ninepoint Medical, Inc. manufacture?

Ninepoint Medical, Inc. specialises in endoscopic optical coherence tomography (OCT) systems. These include imaging probes, consoles, and accessories like single-use catheter/overtube balloon inflators and marking probes. The devices are designed for visualising internal tissue structures and guiding targeted biopsy procedures, with variations in probe sizes and working distances to suit different clinical needs.

Where is Ninepoint Medical, Inc. based, and where are its devices authorised for use?

Ninepoint Medical, Inc. is based in the United States. The company’s devices are authorised for commercial distribution in the US, where they undergo regulatory review to ensure compliance with local standards before market entry.

Which regulatory registries list Ninepoint Medical, Inc.’s devices?

Ninepoint Medical, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries track devices that have undergone the 510(k) premarket notification process, demonstrating they meet applicable regulatory requirements for safety and effectiveness in the US.

How are Ninepoint Medical, Inc.’s devices classified under US regulations?

Ninepoint Medical, Inc.’s devices fall under Class II regulatory classification in the US. This classification applies to devices that generally pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness before authorisation.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: ninepointmedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 855-900-7203
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 961880999

Catalogue (34)

Device	Model / Reference	Registries	Class	Status
NvisionVLE Imaging Probe 17mm	95101-17	FDA UDI	Class II	Active
NvisionVLE Marking Console with IRIS	94301-MI	FDA UDI	Class II	Active
NvisionVLE Marking Probe 14mm Clinical	95301-M-14C	FDA UDI	Class II	Active
NvisionVLE Inflation Kit	96101-60	FDA UDI	Class II	Active
NvisionVLE Marking Probe 20mm	95301-M-20	FDA UDI	Class II	Active
NvisionVLE Low Profile Imaging Probe, 20mm Working Distance	95501-20	FDA UDI	Class II	Active
NvisionVLE Marking Probe 20mm Clinical	95301-M-20C	FDA UDI	Class II	Active
NvisionVLE Marking Probe 14mm	95301-M-14	FDA UDI	Class II	Active
NvisionVLE Marking Console Refurbished	94301-M-R	FDA UDI	Class II	Active
NvisionVLE Low Profile Imaging Probe, 14mm Working Distance	95501-14	FDA UDI	Class II	Active
NvisionVLE Marking Console with IRIS, Upgraded	94301-MI-UPG	FDA UDI	Class II	Active
NvisionVLE Imaging System with Targeted Biopsy - Upgrade	94301-M-UPG	FDA UDI	Class II	Active
NvisionVLE Imaging Console	94101	FDA UDI	Class II	Active
NvisionVLE Low Profile Imaging Probe, 0mm Working Distance	95501-LP	FDA UDI	Class II	Active
NvisionVLE Marking Upgrade Refurbished	94301-M-UPG-R	FDA UDI	Class II	Active
NvisionVLE Imaging Probe 20mm Clinical	95101-20C	FDA UDI	Class II	Active
NvisionVLE Marking Console with IRIS, Upgraded, Refurbished	94301-MI-UPG-R	FDA UDI	Class II	Active
NvisionVLE Imaging Probe 20mm	95101-20	FDA UDI	Class II	Active
NvisionVLE Imaging Probe 14mm	95101-14	FDA UDI	Class II	Active
NvisionVLE Imaging Probe 17mm Clinical	95101-17C	FDA UDI	Class II	Active
NvisionVLE Marking Probe 17mm Clinical	95301-M-17C	FDA UDI	Class II	Active
NvisionVLE Marking Probe 17mm	95301-M-17	FDA UDI	Class II	Active
NvisionVLE Imaging Probe 14mm Clinical	95101-14C	FDA UDI	Class II	Active
NvisionVLE Marking Console	94301-M	FDA UDI	Class II	Active
NvisionVLE Imaging Console Refurbished	94101-R	FDA UDI	Class II	Active
NvisionVLE Marking Console with IRIS, Refurbished	94301-MI-R	FDA UDI	Class II	Active
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory	K143678	FDA 510(k)	Class II	Active
NvisionVLE Imaging System, NvisionVLE Optical Probe	K182261	FDA 510(k)	Class II	Active
Nvision Vle Imaging System Nvision Vle Catheter	K121195	FDA 510(k)	Class II	Active
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System	K182616	FDA 510(k)	Class II	Active
Nvision Vle Imaging System, Nvision Vle Catheter	K112770	FDA 510(k)	Class II	Active
NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon, NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System	K153479	FDA 510(k)	Class II	Active
NvisionVLE Low-profile Optical Probe	K191117	FDA 510(k)	Class II	Active
Nvision Vle Imaging System	K120800	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

NinePoint Medical, Inc. has one FDA recall record initiated on 2018-04-11, which is listed with a terminated status. The recall was due to the potential detachment of distal tips from the probe shaft during use.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 11, 2018	Z-1781-2018	—	terminated	Distal tips of the probes may detach from the probe shaft during use.