# Ninepoint Medical, Inc.

- Location (FDA's records): Bedford, MA
- FDA decisions: 8 (2011–2019): 8 510(k) clearances
- Product codes: NQQ (8)
- Predicates its devices cite: 13 (7 its own); citations of its devices by later devices: 9 (7 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Imalux Corporation: 2 (https://510kreport.com/company/imalux)
- Quanta System Spa: 1 (https://510kreport.com/company/quanta-system)
- Chek-Med Systems: 1 (https://510kreport.com/company/chek-med-systems)
- Imalux Coporation: 1 (https://510kreport.com/company/imalux-coporation)
- Tomophase Corporation: 1 (https://510kreport.com/company/tomophase)

## Firms that cite its devices most
- Leadoptik, Inc.: 1 (https://510kreport.com/company/leadoptik)
- Micro-Tech (Nanjing) Co., Ltd.: 1 (https://510kreport.com/company/micro-tech-nanjing)

## Its most-cited devices
- K112770: Nvision Vle Imaging System, Nvision Vle Catheter (2011), cited by 3
- K143678: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory (2015), cited by 2
- K153479: NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System (2016), cited by 1
- K182261: NvisionVLE Imaging System, NvisionVLE Optical Probe (2018), cited by 1
- K120800: Nvision Vle Imaging System (2013), cited by 1
- K182616: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System (2018), cited by 1

## Recent decisions
- K191117: NvisionVLE Low-profile Optical Probe (Jul 19, 2019)
- K182616: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System (Nov 2, 2018)
- K182261: NvisionVLE Imaging System, NvisionVLE Optical Probe (Oct 16, 2018)
- K153479: NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System (Feb 16, 2016)
- K143678: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory (Feb 6, 2015)
- K120800: Nvision Vle Imaging System (Apr 25, 2013)
- K121195: Nvision Vle Imaging System Nvision Vle Catheter (Jul 25, 2012)
- K112770: Nvision Vle Imaging System, Nvision Vle Catheter (Dec 16, 2011)

Source page: https://510kreport.com/company/ninepoint-medical