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 the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Jiyuan Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-10-01 under 510(k) 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. The listed applicant is Jiangsu Jiyuan Medical Technology Co., Ltd.. The 510(k) number is K210270.

When did Medical Endoscope Image Processing System receive FDA 510(k) clearance?

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

Who is the listed applicant for Medical Endoscope Image Processing System?

The FDA 510(k) record lists Jiangsu Jiyuan Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Jiangsu Jiyuan Medical Technology Co., Ltd. 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.

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)

K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument 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)Jiangsu Jiyuan Medical Technology Co., Ltd.K252012SPY Cystoscope/HysteroscopeStryker Endoscopy K243382RZ Resectoscope SystemRz Medizintechnik GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.