510(k) K241593
- Device
- BoneMetrics (US)
- Applicant
- Gleamer Sas
- 510(k) number
- K241593
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-05
- Date received
- 2024-06-03
- 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
- Antoine Tournier
- Address
- 47bis Rue Des Vinaigriers Paris FR 75010 75010
FDA Registration Numbers#
- 3009077524
- 9616251
- 9611992
- 3008007310
- 3008837339
- 3013844297
- 3034527804
- 3013757696
- 3018733944
- 3025603301
- 8020021
- 3013561205
- 3017425832
- 3021637148
- 8043933
- 3042955884
- 3033527283
- 3014146081
- 3014665798
- 3032109181
- 3025343020
- 3017426576
- 3019541896
- 3011763071
- 3036495186
- 3013410552
- 3022719380
- 3005403518
- 1644408
- 2032350
- 9710122
- 3043494619
- 8030233
- 3002619337
- 3030655434
- 3035373446
- 3026970882
- 8022257
- 3014132130
- 2532090
- 3006165260
- 3013306229
- 9614698
- 3043625056
- 3007194257
- 3001675293
- 3001722928
- 3005930550
- 3027347389
- 3044776706
- 3015537315
- 3018094310
- 3014491269
- 8041160
- 3009758186
- 3036725840
- 3017976149
- 3030088963
- 3042175844
- 3045521711
- 1651903
- 3016585383
- 9612283
- 3024820186
- 3040335643
- 3023245
- 3008496839
- 3010398867
- 3031569584
- 3045078825
- 3006985147
- 2126677
- 3028006458
- 3032807464
- 3029937167
- 3027160711
- 1818910
- 3004972322
- 2134213
Source Documents#
Other 510(k) Records For Product Code QIH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260497 | DEEPVESSEL Plaque | Keya Medical Technology Co., Ltd. | 2026-06-04 |
| 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 |