GENTUITY, LLC

FDA Device Registration & Listing · Bedford, MA, US · Registration 3021630097

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021630097
FEI Number
3021630097
Entity Name
GENTUITY, LLC
City/State/Country
Bedford, MA, US
Establishment Address
28 Crosby Drive, Bedford, MA 01730, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Gentuity, LLC (Owner Number: 10073861)
Owner / Operator Contact Address
142 North Road, Suite G, Sudbury, MA 01776, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K192922
PMA Number
N/A

All Registered Proprietary Names

Vis-Rx® Micro-Imaging Catheter Gentuity® HF-OCT Imaging System Gentuity HF-OCT Imaging System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2020-05-15
ORD Optical Coherence Tomography, Intravascular Catheter Cardiovascular Class 2 870.1200 2020-05-15

Official Correspondent

Edwin Rule

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gentuity, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3011578544 GENTUITY, LLC Sudbury, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K183320 St. Jude Medical (Now Abbott Medical) Ilumien Optis, Optis Integrated, Optis Mobile 2019-04-02
K253459 ABBOTT MEDICAL OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) 2026-04-24
K210458 ABBOTT MEDICAL OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System 2021-06-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021630097. Last updated year: 2026. Please use registration number 3021630097 when referencing this establishment in official correspondence.
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