510(k) K254015
- Device
- CoLumbo C-Spine
- Applicant
- Smart Soft Healthcare AD
- 510(k) number
- K254015
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-01
- Date received
- 2025-12-15
- 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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Nedelcho Georgiev
- Address
- 113 General Kolev St. , Primorski District., Office 7.2 Varna BG 9002 9002
FDA Registration Numbers
- 3018302800
- 3025602618
- 3009731198
- 3023217364
- 9710602
- 3035950510
- 3032109181
- 3008007310
- 3025110425
- 3001722928
- 3006985147
- 3029923647
- 3009077524
- 3027986210
- 3017210169
- 1644408
- 3036495186
- 3019216
- 3002808157
- 3016446349
- 3032367
- 3020703662
- 3030088963
- 3025603301
- 9614698
- 8041160
- 3030412475
- 3011015597
- 3007194257
- 3013497030
- 3014809646
- 3014310698
- 3033527283
- 9680825
- 9617277
- 3042248552
- 3010656400
- 3026970882
- 3021887566
- 9611125
- 3002619337
- 3031569584
- 3015516266
- 3019541896
- 3007545404
- 3006165260
- 3027645731
- 3024972425
- 3016824824
- 3028006458
- 3035373446
- 3043494619
- 3016461002
- 3004141078
- 3017058304
- 3019878658
- 8020021
- 3020928588
- 1651903
- 3002183074
- 3021032044
- 3005383085
- 3010952312
- 3018733944
- 3039211310
- 1226773
- 1826555
- 3014665798
- 3012747207
- 3011950073
- 3017936680
- 3003594449
- 3023245
- 3014132130
- 3016579137
- 3030446846
- 3007630531
- 3007734888
- 3032807464
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code QIH
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252708 | Relu Cloud | Relu BV | 2026-04-10 |
| K253930 | Overjet Iris Intelligent Imaging System | Overjet, Inc. | 2026-04-10 |
| K253689 | syngo Dynamics (VA41F) | Siemens Healthcare GmbH | 2026-04-10 |
| K254207 | AiORTA - Plan v2.0 | ViTAA Medical Solutions, Inc. | 2026-03-30 |