510(k) K243227
- Device
- B-Scan
- Applicant
- Accutome, Inc. Doing Business AS Keeler USA
- 510(k) number
- K243227
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-11
- Date received
- 2024-10-08
- 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
- N
Applicant Contact#
- Contact
- Claudia Hill
- Address
- 3222 Phoenixville Pike Malvern PA US 19355 19355
FDA Registration Numbers#
- 3003594449
- 3003681187
- 3004009431
- 3008640801
- 2031044
- 3008321254
- 3035373446
- 3010280625
- 2518586
- 3005785090
- 3033743848
- 2936921
- 1216677
- 3009600098
- 3005875675
- 1000602763
- 3010703925
- 3033710058
- 3026405201
- 2320762
- 9610632
- 3008515880
- 2133810
- 9617592
- 3015973732
- 9614587
- 3015525240
- 9613249
- 3015972810
- 9710090
- 2134243
- 3019784575
- 3016171942
- 9680269
- 1126271
- 3003600763
- 3008363989
- 2024168
- 3007603826
- 1066427
- 3034286426
- 3002808148
- 3034232408
- 3033557977
- 3012811961
- 3011278898
- 3006382185
- 3012387143
- 3016076141
- 3010041511
- 9617277
- 3023245
- 3004569406
- 3042225166
- 3043534483
- 3017654247
- 2025099
- 3010663777
- 3011137372
- 3010760216
- 3017057763
- 3007015148
- 3006161756
- 3009756153
- 3016696283
- 2134812
- 3007738736
- 3017233611
- 3013764800
- 2032350
- 3026047529
- 3013840437
- 3011686611
- 3012081348
- 2522950
- 3012198618
- 1000513161
- 1319660
- 2030624
- 3008950127
Source Documents#
Other 510(k) Records For Product Code IYO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260605 | Lilium one (USM330) | Lilium Otsuka Co., Ltd. | 2026-10-16 |
| K260313 | MD-6000S Bladder Scanner | MEDA Co., Ltd. | 2026-09-24 |
| 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 |
| 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 |