510(k) K881336
- Device
- BRYMASCAN-A
- Applicant
- BRYMILL CORP.
- 510(k) number
- K881336
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-03-14
- Date received
- 1988-03-29
- Regulation
- 892.1560
- Classification name
- System, Imaging, Pulsed Echo, Ultrasonic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL D BRYNE
- Address
- P.O. Box 2392 Vernon CT US 06066 06066
FDA Registration Numbers#
- 3014279513
- 1937397
- 3002619337
- 8043933
- 3015806723
- 3024838922
- 3005860720
- 3017968993
- 3033743848
- 2936921
- 3031564213
- 2024168
- 3015997711
- 3016076141
- 3031158
- 9710090
- 8010047
- 3016854601
- 1012187
- 3009247326
- 3017944270
- 3015499445
- 3017057763
- 3003774756
- 3012204368
- 3015276088
- 3003681187
- 2433682
- 3004009431
- 1054713
- 3008950127
- 3008386005
- 3012127758
- 3010082909
- 3015972810
- 3006979678
- 3038718997
- 3008253300
- 3003971136
- 2518897
- 3016842138
- 3008548323
- 3037874486
- 2134812
- 2124215
- 3008640801
- 2522950
- 1055236
- 1650907
- 9610595
- 3006110251
- 3017636737
- 1319660
- 8020021
- 3029937167
- 3005875675
- 1216677
- 3012494290
- 2031962
- 3043534483
- 3003647374
- 3017233611
- 3009212453
- 3009565060
- 3012939903
- 9615849
- 3002315840
- 2521877
- 3014639846
- 3007994837
- 1000269286
- 3032807464
- 3007738736
- 3011599810
- 3042470731
- 2182318
- 1528028
- 3032109181
- 3011396687
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
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