# Lightlab Imaging, Inc.

- Location (FDA's records): Westford, MA
- FDA decisions: 10 (2010–2016): 10 510(k) clearances
- Product codes: NQQ (8), DQO (2)
- Predicates its devices cite: 13 (9 its own); citations of its devices by later devices: 21 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Radi Medical Systems AB: 2 (https://510kreport.com/company/radi-medical-systems)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Boston Scientific, Target: 1 (https://510kreport.com/company/boston-scientific-target)

## Firms that cite its devices most
- Shenzhen Vivolight Medical Device & Technology Co., Ltd.: 3 (https://510kreport.com/company/shenzhen-vivolight-medical-device-technology)
- Abbott Medical: 2 (https://510kreport.com/company/abbott-medical)
- Gentuity, LLC: 2 (https://510kreport.com/company/gentuity)
- St. Jude Medical (Now Abbott Medical): 1 (https://510kreport.com/company/st-jude-medical-now-abbott-medical)
- Terumo Corp.: 1 (https://510kreport.com/company/terumo)
- Terumo Cardiovascular Systems Thi Plant: 1 (https://510kreport.com/company/terumo-cardiovascular-systems-thi-plant)
- Conavi Medical, Inc.: 1 (https://510kreport.com/company/conavi-medical)
- Avinger, Inc.: 1 (https://510kreport.com/company/avinger)

## Its most-cited devices
- K141453: Ilumien Optis, Dragonfly Optis Imaging Catheter (2014), cited by 5
- K141769: Optis Integrated System, Dragonfly Optis Imaging Catheter (2014), cited by 3
- K152120: OPTIS Mobile System (2015), cited by 3
- K150878: Ilumien Optis (2015), cited by 2
- K093857: C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable Accessories (2010), cited by 2
- K123369: Ilumien Optis (2013), cited by 2

## Recent decisions
- K160878: OPTIS Metallic Stent Optimization E.4 SW (Jun 29, 2016)
- K152120: OPTIS Mobile System (Oct 29, 2015)
- K151286: OPTIS Integrated System Mobile Workstation (Aug 5, 2015)
- K150878: Ilumien Optis (Jul 15, 2015)
- K150237: ILUMIEN, Drageonfly OPTIS Imaging Catheter (May 5, 2015)
- K141453: Ilumien Optis, Dragonfly Optis Imaging Catheter (Sep 19, 2014)
- K141769: Optis Integrated System, Dragonfly Optis Imaging Catheter (Aug 18, 2014)
- K123369: Ilumien Optis (Jan 30, 2013)

Source page: https://510kreport.com/company/lightlab-imaging