Data / Medical devices / System, Imaging, Optical Coherence Tomography (Oct) / United States
FDA-registered makers of System, Imaging, Optical Coherence Tomography (Oct) in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make System, Imaging, Optical Coherence Tomography (Oct) (product code NQQ). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- System, Imaging, Optical Coherence Tomography (Oct)
- Product code
- NQQ
- Country
- United States
Makers of System, Imaging, Optical Coherence Tomography (Oct) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Medical | Westford, MA, United States | Manufacturer, Specification developer | 9 | April 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Spectrawave, Inc. | Bedford, MA, United States | Manufacturer | 5 | December 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Gentuity, LLC | Sudbury, MA, United States | Complaint file establishment, Manufacturer | 1 | February 20, 2020 | 0 | 0 | 0 | api.fda.gov |
| Gentuity, LLC | Bedford, MA, United States | Manufacturer | 1 | February 20, 2020 | 0 | 0 | 0 | api.fda.gov |
| Leadoptik Inc. | San Jose, CA, United States | Manufacturer | 1 | December 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical | Roseville, MN, United States | Manufacturer | 1 | August 10, 2011 | 0 | 0 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Thi Plant | Ann Arbor, MI, United States | Manufacturer | 1 | July 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Life Science Outsourcing | Somersworth, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RBC Development LLC dba RBC Medical Innovations dba Vantage MedTech | Olathe, KS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.