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FDA 510(k)

Stellar Imaging System

K-Number: K241530 · 2024-08-07

ApplicantGuangdong Optomedic Technologies, Inc.
Decision Date2024-08-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Stellar Imaging System is a medical device manufactured by Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2024-08-07 under approval number K241530. 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 Stellar Imaging System?

Stellar Imaging System is a medical device that received FDA 510(k) clearance on 2024-08-07. It is manufactured by Guangdong Optomedic Technologies, Inc.. The 510(k) number is K241530.

When was Stellar Imaging System approved by the FDA?

Stellar Imaging System received FDA 510(k) clearance on 2024-08-07, under approval number K241530.

What company makes Stellar Imaging System?

Stellar Imaging System is manufactured by Guangdong Optomedic Technologies, Inc..

What is the FDA product code for Stellar Imaging System?

The FDA product code for Stellar Imaging System is GCJ.

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Related PubMed Literature

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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 K242513FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)

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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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