510(k) K202856
- Device
- Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Sup
- Applicant
- Edan Instruments, Inc.
- 510(k) number
- K202856
- Product code
- IYN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-01-25
- Date received
- 2020-09-28
- 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
- Ying Dai
- Address
- 15 Jinhui Rd., Jinsha Community, Kengzi Sub-District, Pingshan District, Shenzhen CN 518122 518122
FDA Registration Numbers#
- 3009286597
- 3003594449
- 3003681187
- 3009715136
- 3013368530
- 2521877
- 3008640801
- 3013757696
- 3010390468
- 3009758186
- 2939830
- 3005406110
- 2031044
- 2518586
- 1416980
- 3004752776
- 3003774756
- 3032109181
- 3012428212
- 3005334138
- 1045254
- 3021226419
- 3014639846
- 9710602
- 3032008018
- 8010047
- 2221819
- 3009196578
- 1000602763
- 3010703925
- 3005860720
- 3008921662
- 3002619337
- 3033710058
- 3012411160
- 3011050570
- 3006441164
- 3010082909
- 3003589956
- 3006680097
- 3016436764
- 3006260740
- 3014755924
- 3004753388
- 3011162972
- 3003851073
- 3000976525
- 3026405201
- 3017955833
- 3040391009
- 3039935725
- 3011200896
- 2133810
- 3013041594
- 1054713
- 3009293490
- 8020021
- 3003637092
- 3010398867
- 3012747207
- 8043836
- 3047889344
- 2245304
- 3019216
- 3008492462
- 3009212453
- 3002183074
- 1000601180
- 3027501622
- 3017944270
- 3014555455
- 9610595
- 3015525240
- 3033858858
- 3004987887
- 3042172882
- 3003647374
- 9710090
- 3033527283
- 3015276088
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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