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FDA 510(k)

FloNavi Open Field Fluorescence Imaging System

K-Number: K230407 · 2023-07-17

ApplicantGuangdong Optomedic Technologies, Inc.
Decision Date2023-07-17
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FloNavi Open Field Fluorescence Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2023-07-17 under 510(k) number K230407. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FloNavi Open Field Fluorescence Imaging System?

FloNavi Open Field Fluorescence Imaging System is a medical device that received FDA 510(k) clearance on 2023-07-17. The listed applicant is Guangdong Optomedic Technologies, Inc.. The 510(k) number is K230407.

When did FloNavi Open Field Fluorescence Imaging System receive FDA 510(k) clearance?

FloNavi Open Field Fluorescence Imaging System received FDA 510(k) clearance on 2023-07-17, under 510(k) number K230407.

Who is the listed applicant for FloNavi Open Field Fluorescence Imaging System?

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

What is the FDA product code for FloNavi Open Field Fluorescence Imaging System?

The FDA product code for FloNavi Open Field Fluorescence Imaging System is OWN.

Related PubMed Literature

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.

PMID: 33715318Review of successful pathways for regulatory approvals in open-field fluorescence-guided surgery.Journal of biomedical optics (2021)

Other records listing Guangdong Optomedic 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.

K252318Insufflator (OPTO-IFL1000)K2526973D LaparoscopeK242513FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)K241530Stellar Imaging SystemK231342Insufflator (OPTO-IFL1000)K231003Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)

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Related Devices (Code: OWN)

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.

K254180PerfusiX-ImagingLIMIS Development B.V.K242163SmartSurgN Visualization SystemSmartsurgN, Inc.K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KGK251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.K260108L12 LED Light Source with AIMStryker EndoscopyK253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG

Official Source

View on FDA Database →

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