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
Related Records
Applicant Contact
- Contact
- Claudia Hill
- Address
- 3222 Phoenixville Pike Malvern PA US 19355 19355
FDA Registration Numbers
- 3002808148
- 2939830
- 1450662
- 3031397684
- 1319721
- 3031564213
- 1054713
- 3010457937
- 3011278898
- 1937397
- 3006260740
- 3011599810
- 1216677
- 2918630
- 3032367
- 3011411309
- 3010663777
- 3008487708
- 3011050570
- 3010390468
- 1319660
- 3017968993
- 3008950127
- 3008321254
- 3011416394
- 3010952312
- 3005810333
- 3025786376
- 3016171942
- 3003594449
- 3017406171
- 1066270
- 8043933
- 3014279513
- 3033508292
- 3007603826
- 9611343
- 3007015148
- 3012387143
- 3013041594
- 3040391009
- 3038718997
- 9612283
- 9610816
- 1450908
- 3003857828
- 3003600763
- 3011686611
- 3008223664
- 3005210579
- 3012198618
- 3012104670
- 2531814
- 3009756153
- 1000314502
- 2029275
- 2244725
- 3029744051
- 2936921
- 3008253300
- 3033275035
- 3007994837
- 3034286426
- 3006680097
- 3016271578
- 3033858858
- 3014639846
- 3032109225
- 3016493665
- 3014680735
- 9680671
- 3031158
- 1834003
- 9613067
- 9611031
- 3026047529
- 1224842
- 9611033
- 3006581049
- 9617592
- 3032109181
- 3002807315
- 1012187
- 3031823165
- 3005646850
- 3012811961
- 1066427
- 3008132411
- 3008515880
- 3005636544
- 3011162972
- 3008548323
- 2024168
- 3016096098
- 3012038665
- 3017636737
- 2024024
- 9615439
- 2521877
- 1826555
- 3023245
- 1422634
- 3006161756
- 1043214
- 3042225166
- 1058584
- 3017057763
- 3009758186
- 3004035727
- 3006540052
- 1000601180
- 3012428212
- 3012204368
- 2532090
- 3017944270
- 3016842138
- 3006110251
- 3006786907
- 3014745562
- 1222780
- 3012981490
- 9615849
- 9710090
- 3013403214
- 3016253057
- 3033527241
- 3006382185
- 2939520
- 3017894900
- 2030624
- 3033557977
- 3010220244
- 1720929
- 3005785090
- 3005406110
- 3032008018
- 3004977335
- 2434141
- 3015551113
- 3013515803
- 1650907
- 9610595
- 1126271
- 3042254626
- 3011396687
- 3009196578
- 3007740628
- 3006597338
- 2025099
- 3010041511
- 1054241
- 3009212453
- 9680794
- 3009499478
- 3010102386
- 2031962
- 3017697447
- 3042470731
- 3007562060
- 3008355361
- 3010610157
- 2134848
- 3042172882
- 3011648943
- 1528028
- 2221819
- 3005877899
- 3008921662
- 1527493
- 1061124
- 3012411160
- 2245539
- 3005860720
- 3027501622
- 3009156722
- 3017654247
- 3009077524
- 3033743848
- 3014432311
- 3019784575
- 3018884581
- 3015806723
- 9614698
- 3002807715
- 8041160
- 2182318
- 3007194257
- 9617277
- 9611125
- 1721676
- 3033710058
- 3037874486
- 3002315840
- 3035373446
- 3005099803
- 3010280625
- 3017955833
- 3017263724
- 3012747207
- 3005334138
- 9610632
- 1000602763
- 2518897
- 3032807464
- 3008729547
- 2518586
- 3016436764
- 1000269286
- 3007738736
- 3016076141
- 3015151147
- 3004753388
- 3042585081
- 3010258456
- 3004705634
- 3003832357
- 3015276088
- 9613249
- 3010398867
- 3010082909
- 3004569406
- 3016854601
- 9611665
- 3015499445
- 3008386005
- 3000126629
- 3012494290
- 3013764800
- 1930027
- 3003589956
- 2954783
- 2133810
- 3012127758
- 1047843
- 3029937167
- 3010034260
- 3017487805
- 3010933511
- 3026405201
- 2124215
- 3013944123
- 9680269
- 3015525240
- 3010193531
- 3003647374
- 3009293490
- 3009529630
- 3011106828
- 3005403518
- 3011692238
- 3011137372
- 2011171
- 3009565060
- 3004485675
- 3013757696
- 3025429169
- 3021226419
- 2184149
- 3010827261
- 9710602
- 3035950510
- 3004009431
- 2433682
- 3006985147
- 3019216
- 2134265
- 3009247326
- 3014555455
- 3015997711
- 3033527283
- 3009407891
- 3002619337
- 3031569584
- 2031044
- 3022472
- 3017233611
- 8020021
- 3002183074
- 3010760216
- 3004574050
- 3003412859
- 3003537036
- 2522950
- 3013840437
- 3012939903
- 1055236
- 3010400367
- 3013535906
- 3007695959
- 3008363989
- 3012402886
- 3011200896
- 3003899230
- 3007836437
- 3003774756
- 3010703925
- 3029906632
- 3008506949
- 2245304
- 3012081348
- 3034232408
- 3005875675
- 3014755924
- 3003971136
- 2320762
- 3008595936
- 1226587
- 3024838922
- 9610482
- 3015973732
- 3016696283
- 8043817
- 1220477
- 3043534483
- 3012987001
- 8010047
- 2032350
- 9614587
- 2134812
- 3003681187
- 3014574557
- 3006979678
- 3001763079
- 3014302721
- 2523891
- 3011763071
- 3015972810
- 3016678045
- 3008496839
- 3015506965
- 9616774
- 2212018
- 3006330030
- 3009715136
- 8030392
- 3009435759
- 1000391004
- 3008640801
- 2134243
- 3011688715
- 3009600098
- 3013844297
- 3010381606
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 |
| 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 |
| K233579 | SC1 Handheld Ultrasound Imaging system (Model: SC1) | Fcu Co., Ltd. | 2024-06-26 |