510(k) K260497
- Device
- DEEPVESSEL Plaque
- Applicant
- Keya Medical Technology Co., Ltd.
- 510(k) number
- K260497
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-04
- Date received
- 2026-02-13
- Regulation
- 892.2050
- Classification name
- Automated Radiological Image Processing Software
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Ning Li
- Address
- #1502-1, 1502-2, 1502-3, Floor 15, Bldg. 1, Yard #1, Ronghua Beijing CN 100176 100176
FDA Registration Numbers#
- 3004141078
- 3010656400
- 3002619337
- 3035386366
- 3006165260
- 8043933
- 3015218501
- 3042928350
- 3027645731
- 1818910
- 3007734888
- 3018733944
- 3017233423
- 3017894900
- 3035950510
- 3014310698
- 3021887566
- 3010398867
- 3020703662
- 2518586
- 3005225421
- 3044776706
- 3024812789
- 9611125
- 2936485
- 3025602618
- 9617277
- 8022257
- 3010703925
- 3017058304
- 3029900829
- 3014665798
- 3033509898
- 9710090
- 2032350
- 3015425142
- 3016824824
- 3005403518
- 3013497030
- 3029923647
- 3023217364
- 3017297314
- 3030598283
- 3013410552
- 3042852277
- 3011950073
- 3017936978
- 3030088963
- 9612283
- 3036495186
- 1826555
- 3006985147
- 3014745562
- 1836549
- 3008284470
- 3006209933
- 3032008018
- 2126677
- 9610482
- 3008693672
- 3015276088
- 3029915548
- 3015516266
- 9613445
- 3039211310
- 3013561205
- 3004972322
- 3008496839
- 9680825
- 3016579137
- 9616251
- 3010952312
- 3015169361
- 3015763655
- 3017210169
- 3021027284
- 3023245
- 3015509619
- 3018064242
Source Documents#
Other 510(k) Records For Product Code QIH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260077 | OrthoGrid Hip AI® 4.0 | OrthoGrid Systems, Inc. | 2026-05-29 |
| K261405 | ANDI 2.2 | Imeka Solutions, Inc. | 2026-05-28 |
| K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | Canon Medical Informatics, Inc. | 2026-05-22 |
| K260234 | MSK Go | Smart Alfa Teknoloji San. Ve Tic. A.S. | 2026-05-21 |
| K254131 | BAC | DeepHealth, Inc. | 2026-05-21 |
| K261289 | UNiD™ Spine Analyzer (SW3002) | Medicrea International S.A.S. (Medtronic) | 2026-05-15 |
| K261273 | Neurophet AQUA | Neurophet., Inc. | 2026-05-15 |
| K254120 | SubtleHD-CT (1.x) | Subtle Medical, Inc. | 2026-05-15 |
| K252563 | Neurophet SCALE PET | Neurophet., Inc. | 2026-05-15 |
| K260032 | Morph | BeauBrain Healthcare, Inc. | 2026-05-13 |
| K254189 | Synapse 3D Base Tools (V7.2) | Fujifilm Corporation | 2026-04-30 |
| K254184 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2026-04-29 |
| K260785 | DS Core CBCT Anatomy | Dentsply Sirona | 2026-04-23 |
| K253077 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-22 |
| K252332 | Folliscan | Mim Fertility | 2026-04-20 |