PINPOINT Endoscopic Fluorescence Imaging System
K-Number: K150956 · 2016-05-23
ApplicantNovadaq Technologies, Inc.
Decision Date2016-05-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
PINPOINT Endoscopic Fluorescence Imaging System is a medical device manufactured by Novadaq Technologies, Inc.. It received FDA 510(k) clearance on 2016-05-23 under approval number K150956. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PINPOINT Endoscopic Fluorescence Imaging System?
PINPOINT Endoscopic Fluorescence Imaging System is a medical device that received FDA 510(k) clearance on 2016-05-23. It is manufactured by Novadaq Technologies, Inc.. The 510(k) number is K150956.
When was PINPOINT Endoscopic Fluorescence Imaging System approved by the FDA?
PINPOINT Endoscopic Fluorescence Imaging System received FDA 510(k) clearance on 2016-05-23, under approval number K150956.
What company makes PINPOINT Endoscopic Fluorescence Imaging System?
PINPOINT Endoscopic Fluorescence Imaging System is manufactured by Novadaq Technologies, Inc..
What is the FDA product code for PINPOINT Endoscopic Fluorescence Imaging System?
The FDA product code for PINPOINT Endoscopic Fluorescence Imaging System is GCJ.
Related Clinical Trials
NCT01143454
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
RECRUITING
NCT03331380
Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
RECRUITING
NCT07276815
OverStitch NXT Endoscopic Suture System
NOT_YET_RECRUITING
NCT04981223
Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
COMPLETED
NCT05197530
Imaging of Lymphatic Vessels in People With Rheumatoid Arthritis (RA)
RECRUITING
NCT07608614
Sleep and Performance
RECRUITING
Related PubMed Literature
PMID: 41887630
Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa.
BMJ open (2026)
PMID: 40775988
B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation.
Studies in health technology and informatics (2025)
PMID: 40346298
An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients.
NPJ digital medicine (2025)
Other Devices by Novadaq Technologies, Inc.
Related Devices (Code: GCJ)
K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien
K160801Well Lead Extraction BagWell Lead Medical Co., Ltd.
K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp.
K161720Standard ClampStandard Bariatrics
K162445LiVac Retractor SystemLivac Pty, Ltd.
K162584VersaOne Bladeless TrocarCovidien
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.