510(k) K071134
- Device
- SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM
- Applicant
- SONOSITE,INC.
- 510(k) number
- K071134
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-05-08
- Date received
- 2007-04-23
- 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
- Yes
Applicant Contact#
- Contact
- DAINA L GRAHAM
- Address
- 21919 30th Dr. SE Bothell WA US 98021 98021
FDA Registration Numbers#
- 3011599810
- 3009435759
- 3011692238
- 1000601180
- 3019216
- 2320762
- 3002183074
- 3010952312
- 3042225166
- 3015506965
- 3025786376
- 1066427
- 1226587
- 3012761544
- 2518897
- 3010827261
- 3009756153
- 3016171942
- 2939520
- 3002808148
- 8043933
- 3013535906
- 3014302721
- 3015973732
- 3029937167
- 2025099
- 3015276088
- 9611033
- 9680579
- 3032807464
- 3011763071
- 2939830
- 3009196578
- 3013840437
- 1000269286
- 2134812
- 3004485675
- 2221819
- 3011200896
- 3017487805
- 1930027
- 3014574557
- 9613249
- 3017057763
- 1650907
- 3003589956
- 3010933511
- 3007194257
- 3004753388
- 2433682
- 3006540052
- 9680794
- 3008363989
- 2024168
- 3007603826
- 3031823165
- 3014745562
- 9614587
- 3010220244
- 3008595936
- 3011137372
- 1319721
- 9610632
- 3007740628
- 3012428212
- 3010703925
- 3012494290
- 9710090
- 1047843
- 3012204368
- 3012987001
- 3031569584
- 1216677
- 3003899230
- 2954783
- 2031962
- 3007994837
- 3014680735
- 3013844297
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#
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