Data / Medical devices / United States / Abbott Medical
Abbott Medical: FDA-registered device maker in Westford, MA, United States, 15 510(k) clearances
Abbott Medical is registered with the FDA (registration 3009600098) in Westford, MA, United States. It lists 8 device types. The FDA files 15 510(k) clearances under its listings, the newest dated April 24, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009600098
- Address
- 4 Robbins Rd, Westford, MA, United States, 01886
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 2, 2013
- Registered through
- 2026
- Brand names listed
- AptiVue Imaging Software version E.6, Dragonfly OPTIS Imaging Catheter Kit, Dragonfly OpStar Imaging Catheter., E.4 Metallis Stent Optimization E.4 SW, ILUMIEN OPTIS Mobile System, ILUMIEN OPTIS Mobile System Accessories, ILUMIEN OPTIS, OPTIS Integrated, OPTIS Mobile with AptiVue Software version E.5.2, ILUMIEN System and Accessories with Dragonfly OPTIS Imaging Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | DQO | 2 | Manufacturer | accessdata.fda.gov |
| Computer, Blood-Pressure | DSK | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Pressure, Catheter Tip | DXO | 2 | Specification developer | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Specification developer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 24, 2026 | K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | NQQ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| September 8, 2023 | K232386 | ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6 | NQQ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| April 14, 2023 | K230411 | Dragonfly OpStar Imaging Catheter | DQO | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| April 30, 2022 | K220243 | Ultiri Measurement System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| June 8, 2021 | K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System | NQQ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 17, 2019 | K192267 | ILUMIEN System with AptiVue Software version D.3 | DQO | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| April 2, 2019 | K183320 | Ilumien Optis, Optis Integrated, Optis Mobile | NQQ | Substantially Equivalent | St. Jude Medical (Now Abbott Medical) | accessdata.fda.gov |
| March 28, 2018 | K180558 | PressureWire X | DXO | Substantially Equivalent | St. Jude Medical (Now Part of Abbott Medical) | accessdata.fda.gov |
| August 18, 2017 | K172182 | QUANTIEN Measurement System | DQK | Substantially Equivalent | St. Jude Medical (Now Part of the Abbott Medical) | accessdata.fda.gov |
| June 29, 2016 | K160878 | OPTIS Metallic Stent Optimization E.4 SW | NQQ | Substantially Equivalent | Lightlab Imaging, Inc. | accessdata.fda.gov |
| October 29, 2015 | K152120 | OPTIS Mobile System | NQQ | Substantially Equivalent | Lightlab Imaging, Inc. | accessdata.fda.gov |
| August 5, 2015 | K151286 | OPTIS Integrated System Mobile Workstation | NQQ | Substantially Equivalent | Lightlab Imaging, Inc. | accessdata.fda.gov |
| July 15, 2015 | K150878 | ILUMIEN OPTIS | NQQ | Substantially Equivalent | Lightlab Imaging, Inc. | accessdata.fda.gov |
| May 5, 2015 | K150237 | ILUMIEN, Drageonfly OPTIS Imaging Catheter | NQQ | Substantially Equivalent | Lightlab Imaging, Inc. | accessdata.fda.gov |
| March 28, 2013 | K123984 | QUANTIEN MEASUREMENT SYSTEM | DQK | Substantially Equivalent | Radi Medical Systems AB | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Blood-Pressure
- All makers of Computer, Diagnostic, Programmable
- All makers of System, Imaging, Optical Coherence Tomography (Oct)
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Wire, Guide, Catheter
Updated April 24, 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.