510(k) K171900
- Device
- Acclarix AX4 Diagnostic Ultrasound System
- Applicant
- Edan Instruments, Inc
- 510(k) number
- K171900
- Product code
- IYN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-08-18
- Date received
- 2017-06-26
- Regulation
- 892.1550
- Classification name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Crystal Cai
- Address
- 15 Jinhui Rd., Jinsha Community, Kengzi Sub-District, Pingshan District, Shenzhen CN 518122 518122
FDA Registration Numbers#
- 1000602763
- 3005403518
- 3003600763
- 3005406110
- 3018094310
- 9710090
- 3003774756
- 1062741
- 3008487708
- 3008729547
- 1000513161
- 2518897
- 3014555455
- 8010047
- 3010703925
- 3003589956
- 3017955833
- 9616774
- 3009499478
- 9680269
- 3003899230
- 3010663777
- 2521877
- 3010398867
- 3003681187
- 3005334138
- 3003637092
- 3011686611
- 3016436764
- 1054713
- 2134812
- 3016493665
- 3010390468
- 3026047529
- 3003412859
- 3002808148
- 3009196578
- 3015806723
- 3011137372
- 3009156722
- 3027501622
- 3019216
- 3006260740
- 3006786907
- 3010400367
- 3001722928
- 3021226419
- 3009293490
- 3006985147
- 1066427
- 3023245
- 9615439
- 3012987001
- 3002315840
- 3011278898
- 3012081348
- 3042225166
- 3011162972
- 2221819
- 3014755924
- 3012747207
- 3011050570
- 3016678045
- 3003971136
- 3013844297
- 3019784575
- 3011648943
- 3016854601
- 3009039068
- 3003647374
- 8020021
- 3015525240
- 3042228064
- 3007994837
- 3013757696
- 3007603826
- 1058584
- 3025786376
- 3008223664
Source Documents#
Other 510(k) Records For Product Code IYN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261585 | Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa A Elite); Diagnostic Ultrasound System (Nuewa A MS); Diagnostic Ultrasound System (Nuewa A20 Premium); Diagnostic Ultrasound System (Nuewa A20 Plus); Diagnostic Ultrasound System (Nuewa A18 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-10-16 |
| K261617 | Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W);Diagnostic Ultrasound System (Nuewa I10 Exp);Diagnostic Ultrasound System (Nuewa I10);Diagnostic Ultrasound System (Nuewa I10S);Diagnostic Ultrasound System (Nuewa XI);Diagnostic Ultrasoun | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-10-08 |
| K263150 | V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Diagnostic Ultrasound System; XH10 ONE Diagnostic Ultrasound System; HERA Z10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2026-10-08 |
| K261933 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | 2026-10-02 |
| K262548 | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2026-09-25 |
| K263182 | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2026-09-25 |
| K261313 | Vivid Explorer/Vivid Advanced/Vivid Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-09-02 |
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90) | Sonoscape Medical Corp. | 2026-08-24 |
| K261668 | Venue Go | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | 2026-08-07 |
| K262311 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2026-08-04 |
| K261288 | Handheld Ultrasound Scanner | IMGFAX CO., LTD. | 2026-07-30 |
| K261835 | LOGIQ Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-07-30 |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System; | Samsung Medison Co., Ltd. | 2026-07-28 |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2026-07-27 |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) | Beijing Konted Medical Technology Co.,Ltd | 2026-07-23 |
Legacy Summary#
summary
FDA Review#
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