510(k) K251894

Device: Himaging Bronchscope System
Applicant: Himaging Technology (Shanghai) Co., Ltd.
510(k) number: K251894
Product code: EOQ
Decision: Substantially Equivalent (SESE)
Decision date: 2025-09-23
Date received: 2025-06-20
Regulation: 874.4680
Classification name: Bronchoscope (Flexible Or Rigid)
Medical specialty: Ear, Nose, Throat
Review panel: Ear, Nose, Throat
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Shumei Xu
Address: Rm. 2601 And 2605 (Nominal Rm. 2801 And 2805), # 418 Guiping Rd., Xuhui District Shanghai CN 200233 200233

FDA Registration Numbers

3002808148
2242464
3013283620
9680515
3010280860
3015136743
3006621103
3027205723
3014769442
1221485
3004040397
1833700
2183744
3006546082
3009039068
3015142721
3022631687
3025603301
1037955
3017859830
3011050570
3012797688
3013557562
3010202439
2246552
3005465238
3025749544
3023214418
3013992977
3003678543
9611680
3005099803
3010273867
3013298431
3022472
3013528571
3006984716
3011416394
3040391040
3005382983
1223925
3013666218
1828132
9615393
3007305485
3006174295
1037905
3033628477
9611997
9681147
3010396739
3006161756
3009171251
3021325287
3004083736
3008439484
3001675293
1000484830
3042225166
3007738736
9710524
1526611
3008040402
3003782610
2029015
3007695959
1000393132
3014342096
3025349506
1319639
3006786907
9610691
1220850
3004962788
3016045249
3012322232
3015925378
3004142795
3012843412
9611102

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code EOQ

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K260565	SmartClip Delivery Catheter (ADR-1715)	Elucent Medical	2026-05-14
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K260420	LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)	MacroLux Medical Technology Co., Ltd.	2026-04-08
K250863	FUJIFILM Ultrasonic Endoscope EB-710US	Fujifilm Corporation	2025-12-12
K251731	KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)	Karl Storz SE & CO. KG	2025-12-05
K252045	Ion Endoluminal System (IF1000)	Intuitive Surgical, Inc.	2025-09-23
K252528	Ion Endoluminal System (IF1000)	Intuitive Surgical, Inc.	2025-09-05
K251752	Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)	Shanghai AnQing Medical Instrument Co., Ltd.	2025-08-27
K251823	UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)	Zhejiang UE Medical Corp.	2025-08-11
K250232	Vathin® Video Bronchoscope System	Hunan Vathin Medical Instrument Co., Ltd.	2025-07-25
K250862	EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)	Olympus Medical Systems Corp.	2025-06-23
K244017	FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000	Fujifilm Corporation	2025-06-13
K250118	Disposable Balloon Catheter B5-2C	Olympus Medical Systems Corporation	2025-06-04
K250957	Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)	Olympus Medical Systems Corporation	2025-05-30
K243497	Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US	Shanghai AnQing Medical Instrument Co., Ltd.	2025-05-29