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FDA 510(k)

Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH

K-Number: K221781 · 2023-02-02

ApplicantGuangdong Optomedic Technologies, Inc.
Decision Date2023-02-02
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH is a medical device manufactured by Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2023-02-02 under approval number K221781. 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 Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH?

Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH is a medical device that received FDA 510(k) clearance on 2023-02-02. It is manufactured by Guangdong Optomedic Technologies, Inc.. The 510(k) number is K221781.

When was Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH approved by the FDA?

Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH received FDA 510(k) clearance on 2023-02-02, under approval number K221781.

What company makes Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH?

Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH is manufactured by Guangdong Optomedic Technologies, Inc..

What is the FDA product code for Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH?

The FDA product code for Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH is GCJ.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 39941212 Artificial Intelligence-Empowered Radiology-Current Status and Critical Review. Diagnostics (Basel, Switzerland) (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 K242513FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) K241530Stellar Imaging System

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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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