510(k) K253775
- Device
- SwiftMR
- Applicant
- Airs Medical, Inc.
- 510(k) number
- K253775
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-26
- Date received
- 2025-11-26
- 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
- Markus Cho
- Address
- 13-14f, Keungil Tower, 223, Teheran-Ro, Gangnam-Gu Seoul KR 06142 06142
FDA Registration Numbers#
- 3033527241
- 9710602
- 3013497030
- 3007734888
- 3019544554
- 3016819165
- 3013561205
- 3005225421
- 3016446349
- 3030655434
- 3024972425
- 3028006458
- 3007194257
- 3002183074
- 3013844297
- 8041160
- 3015173173
- 8022257
- 8030233
- 1423253
- 3015169361
- 3026970882
- 3004977335
- 3017487805
- 3016965352
- 8043933
- 3007545404
- 3021637148
- 3033509898
- 3042955884
- 3030446846
- 3025343020
- 3032008018
- 2936485
- 3018094310
- 3024820186
- 3009758186
- 3010102386
- 3009196578
- 3006985147
- 3008693672
- 3002808157
- 3015537315
- 3035386366
- 1644408
- 3001675293
- 9611343
- 1651903
- 2532090
- 3042175844
- 3008007310
- 3010398867
- 3015509619
- 1000432246
- 9680269
- 3013552417
- 3021907554
- 3005403518
- 3014146081
- 3016579137
- 3042243683
- 3000976525
- 1836549
- 1818910
- 3014132130
- 9610482
- 3010703925
- 3014745562
- 3030088963
- 9616251
- 3015276088
- 3029937167
- 3035373446
- 3035950510
- 3029915548
- 3017173128
- 3005930550
- 3014809646
- 3039211310
Source Documents#
Other 510(k) Records For Product Code QIH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252563 | Neurophet SCALE PET | Neurophet., Inc. | 2026-05-15 |
| K254120 | SubtleHD-CT (1.x) | Subtle Medical, 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 |
| K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | Ge Medical Systems, LLC | 2026-04-14 |
| K253930 | Overjet Iris Intelligent Imaging System | Overjet, Inc. | 2026-04-10 |