510(k) K261535
- Device
- Hi-D Imaging 4TAVR
- Applicant
- Hi-D Imaging AG
- 510(k) number
- K261535
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-20
- Date received
- 2026-05-08
- Regulation
- 892.2050
- Classification name
- Automated Radiological Image Processing Software
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Utku Gulan
- Address
- Technoparkstrasse 2 Winterthur CH 8406 8406
FDA Registration Numbers#
- 3015763655
- 3017167291
- 3013844297
- 3024820186
- 3004977335
- 3016446349
- 3002808157
- 9710602
- 9680269
- 3033527241
- 3011015597
- 3013552417
- 1644408
- 3020928588
- 3030412475
- 3027645731
- 3001722928
- 3015537315
- 3042248552
- 2126677
- 3019541896
- 3009196578
- 9612283
- 9611343
- 2032350
- 3043494619
- 3033527283
- 3042852277
- 3016585383
- 3011205675
- 3015425142
- 3016819165
- 3035950510
- 3007194257
- 3011763071
- 3020703662
- 3016461002
- 3018302800
- 3010952312
- 3000976525
- 8020021
- 1000432246
- 3006209933
- 3021032044
- 3012761544
- 3019878658
- 3028006458
- 3008284470
- 1818910
- 3007734888
- 3012987001
- 3011189058
- 3025430791
- 3027977501
- 3042955884
- 1423253
- 3035386366
- 3042902406
- 3015276088
- 3014310698
- 3017210169
- 9710090
- 3017173128
- 3031569584
- 3021887566
- 9680825
- 3005225421
- 3014938447
- 3003775006
- 3014678441
- 3014146081
- 3007630531
- 3010342382
- 3009731198
- 3009758186
- 3021907554
- 3024972425
- 3017426576
- 3025343020
Source Documents#
Other 510(k) Records For Product Code QIH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260192 | DIANA | ROPCA ApS | 2026-07-24 |
| K261349 | SwiftMR | Airs Medical, Inc. | 2026-07-24 |
| K254096 | VELMENI for DENTISTS (V4D) 3D | Velmeni, Inc. | 2026-07-23 |
| K260206 | SkeletonPlanner | UPlanner B.V. - Presurgeo | 2026-07-15 |
| K260973 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026-07-07 |
| K253628 | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. | 2026-06-29 |
| K253969 | ADAS 3D | Adas3D Medical S.L. | 2026-06-29 |
| K253786 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | 2026-06-25 |
| K260316 | CMN Capillary Function with Oncology Virtual Expert | Cercare Medical A/S | 2026-06-22 |
| K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | 2026-06-18 |
| K253172 | MediAI-OA | Crescom Co., Ltd. | 2026-06-15 |
| K253690 | LungMaps | Siemens Healthineers AG | 2026-06-15 |
| K260300 | WatchMate Software | Anumana, Inc. | 2026-06-15 |
| K260406 | Brainomix 360 Hyperdensity | Brainomix Limited | 2026-06-12 |
| K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2026-06-11 |