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FDA 510(k)

FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)

K-Number: K242513 · 2024-10-23

ApplicantGuangdong Optomedic Technologies, Inc.
Decision Date2024-10-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) is a medical device manufactured by Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2024-10-23 under approval number K242513. 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 FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)?

FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) is a medical device that received FDA 510(k) clearance on 2024-10-23. It is manufactured by Guangdong Optomedic Technologies, Inc.. The 510(k) number is K242513.

When was FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) approved by the FDA?

FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) received FDA 510(k) clearance on 2024-10-23, under approval number K242513.

What company makes FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)?

FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) is manufactured by Guangdong Optomedic Technologies, Inc..

What is the FDA product code for FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)?

The FDA product code for FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) is GCJ.

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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 Guangdong Optomedic Technologies, Inc.

K231342Insufflator (OPTO-IFL1000) K230407FloNavi Open Field Fluorescence Imaging System K231003Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) K221861FloNavi Endoscopic Fluorescence Imaging System K221781Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH K241530Stellar Imaging System

View all 9 devices →

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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.

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