510(k) K181313
- Device
- BenQ Diagnostic Ultrasound System
- Applicant
- Qisda Corporation
- 510(k) number
- K181313
- Product code
- IYN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-08-27
- Date received
- 2018-05-17
- 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
- Johnson Sheu
- Address
- #157, Shanying Rd., Gueishan Dist, Taoyuan City TW 333 333
FDA Registration Numbers#
- 3026047529
- 8043933
- 3010041511
- 3003851073
- 3026405201
- 3033275035
- 3043534483
- 1721676
- 2531814
- 3017487805
- 3017955833
- 3016076141
- 3002808148
- 9610482
- 3044744649
- 1000269286
- 3005877899
- 3002315840
- 3006680097
- 2031044
- 3006161756
- 1826555
- 3033508292
- 3014639846
- 1450908
- 3005810333
- 3010381606
- 3010663777
- 3010390468
- 2133810
- 3015276088
- 3012939903
- 1066427
- 3016678045
- 3008921662
- 3032109225
- 3008223664
- 3031397684
- 3009293490
- 3033527283
- 3023245
- 3033527241
- 3012402886
- 3006979678
- 3042172882
- 2518586
- 2518897
- 3004485675
- 3010220244
- 3016436764
- 9610595
- 3019784575
- 1066270
- 3018094310
- 3006786907
- 2939830
- 3012428212
- 3010400367
- 1937397
- 3008492462
- 3033710058
- 1643817
- 3009286597
- 3038718997
- 3003637092
- 1000513161
- 3010760216
- 3010082909
- 3008992312
- 3010703925
- 1058584
- 9615439
- 3006260740
- 3008496839
- 2134812
- 9616774
- 3014574557
- 2245304
- 3035950510
Source Documents#
Other 510(k) Records For Product Code IYN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system | Esonic Technology (Wuhan) Co., Ltd. | 2026-07-23 |
| K260667 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2026-06-29 |
| K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2026-06-16 |
| K260748 | ES-Series | E-Scopics | 2026-06-09 |
Legacy Summary#
summary
FDA Review#
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