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FDA 510(k)

PINPOINT Endoscopic Fluorescence Imaging System

K-Number: K161792 · 2016-09-20

ApplicantNovadaq Technologies, Inc.
Decision Date2016-09-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PINPOINT Endoscopic Fluorescence Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Novadaq Technologies, Inc.. It received FDA 510(k) clearance on 2016-09-20 under 510(k) number K161792. 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 2016-09-20. The listed applicant is Novadaq Technologies, Inc.. The 510(k) number is K161792.

When did PINPOINT Endoscopic Fluorescence Imaging System receive FDA 510(k) clearance?

PINPOINT Endoscopic Fluorescence Imaging System received FDA 510(k) clearance on 2016-09-20, under 510(k) number K161792.

Who is the listed applicant for PINPOINT Endoscopic Fluorescence Imaging System?

The FDA 510(k) record lists Novadaq Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PINPOINT Endoscopic Fluorescence Imaging System?

The FDA product code for PINPOINT Endoscopic Fluorescence Imaging System is GCJ.

Other records listing Novadaq Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemK150956PINPOINT Endoscopic Fluorescence Imaging System

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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