510(k) K904359
- Device
- ESI-3000 ULTRASOUND SYSTEM
- Applicant
- ELSCINT, INC.
- 510(k) number
- K904359
- Product code
- IYN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-03-05
- Date received
- 1990-09-24
- Regulation
- 892.1550
- Classification name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROCHELLE SOBEL
- Address
- 505 Main St. Suite 300 Hackensack NJ US 07601 07601
FDA Registration Numbers#
- 9615849
- 3007603826
- 1054713
- 3003637092
- 2521877
- 2032350
- 3004485675
- 3008492462
- 3014555455
- 3016842138
- 9615439
- 3016076141
- 3005860720
- 9680269
- 3006161756
- 9610482
- 3031823165
- 3016678045
- 3016854601
- 2133810
- 3003774756
- 2245304
- 9614698
- 3008223664
- 2531814
- 2183744
- 3005403518
- 3012981490
- 3015525240
- 3017406171
- 3033710058
- 3019216
- 9616774
- 3042225166
- 3014680735
- 3011278898
- 3010082909
- 3015806723
- 3016436764
- 3029744051
- 3026047529
- 3006382185
- 3032807464
- 3010390468
- 3011050570
- 3013041594
- 3010041511
- 3010952312
- 3026405201
- 3029916061
- 3008386005
- 3008729547
- 3009212453
- 3015276088
- 9710602
- 3031397684
- 3012402886
- 9612283
- 3025786376
- 3009715136
- 3017968993
- 3037874486
- 3014755924
- 2532090
- 3035950510
- 3002808148
- 3033527283
- 2518586
- 3040391009
- 1721676
- 2134213
- 3011200896
- 3011137372
- 1416980
- 3023245
- 3010400367
- 3008950127
- 1000601180
- 3012081348
- 3011648943
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IYN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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