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FDA 510(k)

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

K-Number: K182616 · 2018-11-02

ApplicantNinepoint Medical, Inc.
Decision Date2018-11-02
Product CodeNQQ
Advisory CommitteeRA
DecisionUnknown

Device Summary

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System is a medical device manufactured by Ninepoint Medical, Inc.. It received FDA 510(k) clearance on 2018-11-02 under approval number K182616. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System?

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by Ninepoint Medical, Inc.. The 510(k) number is K182616.

When was NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System approved by the FDA?

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System received FDA 510(k) clearance on 2018-11-02, under approval number K182616.

What company makes NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System?

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System is manufactured by Ninepoint Medical, Inc..

What is the FDA product code for NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System?

The FDA product code for NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System is NQQ.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT06797765 Optical Coherence Tomography Angiography in Neurological Disease COMPLETED NCT02710916 SD-OCT Multimodal Analysis in GLaucoma COMPLETED NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07608614 Sleep and Performance RECRUITING

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41448934 [Regulatory Practices and Implications of FDA Approving New Drug Indication under the Medical Device Pathway]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 41293705 Clinical translation of photoacoustic imaging using exogenous molecular contrast agents [Invited]. Biomedical optics express (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Ninepoint Medical, Inc.

K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System K182261NvisionVLE Imaging System, NvisionVLE Optical Probe K191117NvisionVLE Low-profile Optical Probe

Related Devices (Code: NQQ)

K162466LuminScan (TM) Imaging SystemMicro-Tech (Nanjing) Co., Ltd. K153283VivoSight Dx Topical OCT SystemMichelson Diagnostics, Ltd. K160878OPTIS Metallic Stent Optimization E.4 SWLightlab Imaging, Inc. K160240Perimeter Otis™ 1.0 Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc. K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation SystemNinepoint Medical, Inc. K171560OTIS Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc.

Official Source

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