510(k) K093466
- Device
- HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
- Applicant
- HITACHI MEDICAL SYSTEMS AMERICA, INC.
- 510(k) number
- K093466
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-06-17
- Date received
- 2009-11-06
- 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
- DOUGH THISTLETHWAITE
- Address
- 1959 Summit Commerce Park Twinsburg OH US 44087 44087
FDA Registration Numbers#
- 2954783
- 2245304
- 8010047
- 3013844297
- 3010041511
- 3031397684
- 3017944270
- 3013757696
- 2030624
- 3013535906
- 2024168
- 3043534483
- 3011200896
- 3007603826
- 1000601180
- 3008921662
- 1126271
- 1000391004
- 1930027
- 3003971136
- 3042225166
- 3040391009
- 8030392
- 9615439
- 3019216
- 3031259044
- 3032109181
- 3004574050
- 3012402886
- 3042470731
- 3008363989
- 3011686611
- 3010034260
- 1720929
- 3025429169
- 3011106828
- 3007194257
- 1937397
- 3015973732
- 3006540052
- 3009247326
- 3010663777
- 2531814
- 9616774
- 3008386005
- 3033275035
- 3017487805
- 1066270
- 3029744051
- 3010220244
- 3021226419
- 3032008018
- 1216677
- 3016171942
- 3012747207
- 3035373446
- 3014639846
- 9611031
- 9615849
- 3013840437
- 3009077524
- 2025099
- 9614587
- 3003832357
- 3005210579
- 3005099803
- 3017894900
- 3006680097
- 9617592
- 3008548323
- 3035950510
- 2918630
- 3003537036
- 3032807464
- 9610632
- 3011162972
- 3013403214
- 3033710058
- 3009758186
Source Documents#
Other 510(k) Records For Product Code IYO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K241029 | SpineUs™ System | Verdure Imaging | 2024-10-07 |
| K233977 | Velacur | Sonic Incytes | 2024-09-04 |
Legacy Summary#
summary
FDA Review#
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