510(k) K213254
- Device
- Axialis Ophthalmic Ultrasound System
- Applicant
- Quantel Medical
- 510(k) number
- K213254
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-15
- Date received
- 2021-09-30
- 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
- Bruno Pages
- Address
- 11 Rue Du Bois Joli-Cs40015 Cournon D' Auvergne-Cedex FR 63808 63808
FDA Registration Numbers#
- 3033527241
- 1222780
- 3010258456
- 1000314502
- 3017233611
- 3003774756
- 3004485675
- 9613249
- 3013844297
- 3015525240
- 3042225166
- 1066270
- 3011688715
- 3009600098
- 3011416394
- 3010827261
- 3014574557
- 3015997711
- 3010400367
- 3012387143
- 1047843
- 2134848
- 3010102386
- 3009196578
- 1054241
- 3006161756
- 9610632
- 2245304
- 3012811961
- 3013041594
- 3005403518
- 9611665
- 9610816
- 1220477
- 9610482
- 3015276088
- 3008321254
- 3005406110
- 3008386005
- 9611031
- 3042172882
- 3002619337
- 3002315840
- 3013515803
- 1061124
- 3006581049
- 3008253300
- 3010952312
- 3013535906
- 1226587
- 2320762
- 3003971136
- 3012104670
- 3011200896
- 3010381606
- 3006786907
- 3032109181
- 3000126629
- 3010280625
- 3032109225
- 1054713
- 2184149
- 3008515880
- 3009529630
- 3005860720
- 2032350
- 3012747207
- 3001763079
- 3014432311
- 3007738736
- 3007740628
- 3012981490
- 3015151147
- 3008729547
- 1834003
- 3031564213
- 3016436764
- 1319660
- 3006597338
Source Documents#
Other 510(k) Records For Product Code IYO#
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|---|---|---|---|
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| K254021 | Accuro XV | Rivanna Medical, Inc. | 2026-04-09 |
| K253898 | QT Scanner 2000 Model A | QT Imaging Holdings, Inc. | 2026-03-04 |
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| 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 |