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FDA 510(k)

Medical Endoscope Image Processing System

K-Number: K210270 · 2021-10-01

ApplicantJiangsu Jiyuan Medical Technology Co., Ltd.
Decision Date2021-10-01
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Medical Endoscope Image Processing System is a medical device manufactured by Jiangsu Jiyuan Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-10-01 under approval number K210270. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medical Endoscope Image Processing System?

Medical Endoscope Image Processing System is a medical device that received FDA 510(k) clearance on 2021-10-01. It is manufactured by Jiangsu Jiyuan Medical Technology Co., Ltd.. The 510(k) number is K210270.

When was Medical Endoscope Image Processing System approved by the FDA?

Medical Endoscope Image Processing System received FDA 510(k) clearance on 2021-10-01, under approval number K210270.

What company makes Medical Endoscope Image Processing System?

Medical Endoscope Image Processing System is manufactured by Jiangsu Jiyuan Medical Technology Co., Ltd..

What is the FDA product code for Medical Endoscope Image Processing System?

The FDA product code for Medical Endoscope Image Processing System is HIH.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

Other Devices by Jiangsu Jiyuan Medical Technology Co., Ltd.

K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)

Related Devices (Code: HIH)

K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal DeviceSmith & Nephew, Inc. K160751Symphion Endoscope and Symphion Cervical SheathBoston Scientific K160510MAKO 7Nvision Medical Corporation K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc.

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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