510(k) K151060
- Device
- Ultrasound System SONIMAGE HS1
- Applicant
- KONICA MINOLTA, INC.
- 510(k) number
- K151060
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-06-05
- Date received
- 2015-04-20
- Regulation
- 892.1560
- Classification name
- System, Imaging, Pulsed Echo, Ultrasonic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Shigeyuki Kojima
- Address
- 1 Sakura-Machi Hino-Shi JP 191-8511 191-8511
FDA Registration Numbers#
- 3013844297
- 3007015148
- 1061124
- 3010663777
- 3032367
- 3045030482
- 3017955833
- 3016842138
- 3008729547
- 3012038665
- 2221819
- 3017233611
- 3012204368
- 3014680735
- 3016854601
- 3007695959
- 3003647374
- 3011278898
- 3033527283
- 1224842
- 2244725
- 3014134519
- 3017654247
- 3008386005
- 3014574557
- 3006110251
- 3010760216
- 3008506949
- 2134812
- 3005403518
- 3010280625
- 1055236
- 2212018
- 3010457937
- 3008921662
- 3011648943
- 3008595936
- 3003600763
- 3006597338
- 2245539
- 3010398867
- 9617592
- 3016096098
- 1054241
- 3011200896
- 9610595
- 3006330030
- 3012104670
- 3014555455
- 3006161756
- 3042254626
- 3037874486
- 3023245
- 2523891
- 3009077524
- 3008321254
- 2134243
- 9612283
- 3031158
- 3007738736
- 3017487805
- 3014432311
- 3007603826
- 3008223664
- 3009499478
- 8043817
- 3025429169
- 3012761544
- 2531475
- 8041160
- 3014755924
- 3009293490
- 2134265
- 1422634
- 1721676
- 3033557977
- 3039935725
- 3007740628
- 3043534483
Source Documents#
Other 510(k) Records For Product Code IYO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253452 | Accuro 3S | Rivanna Medical, Inc. | 2026-07-24 |
| K260190 | ARTHUR | ROPCA ApS | 2026-06-18 |
| K252237 | EdgeFlow UW20 | Edgecare, Inc. | 2026-04-17 |
| K254021 | Accuro XV | Rivanna Medical, Inc. | 2026-04-09 |
| K253898 | QT Scanner 2000 Model A | QT Imaging Holdings, Inc. | 2026-03-04 |
| K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | 2026-02-24 |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | Eieling Technology (Shenzhen) Limited | 2026-02-06 |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. | 2025-09-30 |
| K250381 | Deepsight NeedleVue LC1 Ultrasound System | DeepSight Technology, Inc. | 2025-08-01 |
| K243227 | B-Scan | Accutome, Inc. Doing Business AS Keeler USA | 2025-07-11 |
| K251728 | Velacur One (LI-1100) | Sonic Incytes Medical Corp | 2025-06-26 |
| K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-06-17 |
| K243937 | Accuro 3S | Rivanna Medical, Inc. | 2025-05-23 |
| K243479 | EchoGuide (Version 1) | Sonavex, Inc. | 2025-04-23 |
| K242496 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) | Eieling Technology (Shenzhen) Limited | 2024-11-19 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases