510(k) K232231
- Device
- QP-Brain®
- Applicant
- Quibim S.L.
- 510(k) number
- K232231
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-13
- Date received
- 2023-07-27
- 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
- No
Applicant Contact#
- Contact
- Angel Alberich Bayarri
- Address
- Avenida Aragón 30, 13th Floor, Office I-J Valencia ES 46021 46021
FDA Registration Numbers#
- 3045521711
- 3033508292
- 3003899230
- 3002808157
- 3027347389
- 3045078825
- 3017173128
- 3011189058
- 3010157088
- 8041160
- 1226773
- 3042248552
- 3011950073
- 3010656400
- 3035386366
- 8043933
- 9710645
- 3018302800
- 3007630531
- 9612283
- 3021032044
- 3013306229
- 1836549
- 9710122
- 9680269
- 9616047
- 3021637148
- 3034527804
- 3017297314
- 3012761544
- 3016446349
- 3017894900
- 3042470731
- 9611992
- 3042928350
- 3009758186
- 3016965352
- 3035455070
- 3017936978
- 3032367
- 2126677
- 3042852277
- 3022973841
- 3003775006
- 3027645731
- 3014678441
- 3014809646
- 3011015597
- 9610482
- 3008284470
- 8043836
- 3033557977
- 3010342382
- 3047842058
- 3042955884
- 1423253
- 3002619337
- 3030446846
- 3014132130
- 3010703925
- 3033527283
- 3010102386
- 3030088963
- 3020331900
- 3029915548
- 3044737887
- 3006985147
- 3015516266
- 3029900829
- 8020021
- 3042940623
- 2518586
- 3011205675
- 3045817397
- 3024812789
- 3035950510
- 3024820186
- 3011763071
- 3017058304
Source Documents#
Other 510(k) Records For Product Code QIH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253794 | Prostate Core | Lucida Medical, Ltd. | 2026-08-10 |
| K252571 | mdprostate | Mediaire GmbH | 2026-08-07 |
| K253902 | RealGUIDE | 3DIEMME SRL | 2026-08-04 |
| K253835 | Affinity | Hermes Medical Solutions AB | 2026-07-31 |
| K260980 | cmAngio® V2.0 | Curemetrix, Inc. | 2026-07-30 |
| K261210 | Cleerly Plaque | Cleerly, Inc. | 2026-07-29 |
| 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 |
| K261535 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | 2026-07-20 |
| 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 |