Data / Medical devices / United States / Gentuity, LLC
Gentuity, LLC: FDA-registered device maker in Bedford, MA, United States, 1 510(k) clearance
Gentuity, LLC is registered with the FDA (registration 3021630097) in Bedford, MA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 20, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021630097
- Address
- 28 Crosby Drive, Bedford, MA, United States, 01730
- Owner or operator
- Gentuity, LLC (10073861)
- Roles
- Manufacturer
- First device listed
- May 15, 2020
- Registered through
- 2026
- Brand names listed
- Gentuity HF-OCT Imaging System, Gentuity® HF-OCT Imaging System, Vis-Rx® Micro-Imaging Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Optical Coherence Tomography, Intravascular Catheter | ORD | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 20, 2020 | K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | NQQ | Substantially Equivalent | Gentuity, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Optical Coherence Tomography (Oct)
- All makers of Optical Coherence Tomography, Intravascular Catheter
Updated February 20, 2020. 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.