510(k) K260584
- Device
- BoneMRI
- Applicant
- Mriguidance B.V.
- 510(k) number
- K260584
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-21
- Date received
- 2026-02-20
- 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
- Marijn van Stralen
- Address
- Maliesingel 23 Utrecht NL 3581 BG 3581 BG
FDA Registration Numbers#
- 8020021
- 3027986210
- 3025602618
- 3005369776
- 3005739655
- 3017976149
- 3016461002
- 3043625056
- 3042940623
- 8041160
- 3017233423
- 3007194257
- 3036502204
- 3010342382
- 8043933
- 1651903
- 3043494619
- 3018733944
- 3003594449
- 3027245002
- 3014665798
- 3025343020
- 3004977335
- 2518586
- 9612283
- 3013552417
- 9615849
- 3014310698
- 3033508292
- 1644408
- 3005403518
- 3021032044
- 3001722928
- 3033557977
- 3045521711
- 9613445
- 3019878658
- 3013561205
- 3034527804
- 3033509898
- 3045078825
- 3025603301
- 3031915908
- 3000126629
- 3032109181
- 9614698
- 3027160711
- 3030089065
- 3032807464
- 3032367
- 3005930550
- 3014678441
- 9611343
- 3024812789
- 3020331900
- 8022257
- 9611125
- 3013306229
- 3017102960
- 3007301305
- 3021907554
- 3013868968
- 3002619337
- 3036725840
- 3042852277
- 3045817397
- 3013410552
- 3042902406
- 3017489096
- 3024972425
- 3008729547
- 8043836
- 3009758186
- 9616047
- 3011205675
- 3010119782
- 3017487805
- 3016824824
- 3007734888
Source Documents#
Other 510(k) Records For Product Code QIH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262147 | CINA-Aneurysm+ | Avicenna.Ai | 2026-10-19 |
| K261733 | Ligence Heart | UAB Ligence | 2026-10-07 |
| K262134 | NeuroDR | Deep Reasoning Ai, Inc. | 2026-10-07 |
| K260523 | QGuideCT (1.0) | Medis Medical Imaging Systems BV | 2026-10-05 |
| K260055 | syngo.CT Brain Quantification | Siemens Medical Solutions USA, Inc. | 2026-09-25 |
| K262390 | BoneXpert | Visiana | 2026-09-22 |
| K261368 | Rapid Platform (R6.7) | Ischemaview, Inc. | 2026-09-21 |
| K261623 | EchoPAC Software Only / EchoPAC Plug-in (v211) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-09-16 |
| K261677 | Artificial Intelligence Renal Assessment (AIRA) Version 1 | Aramis Global AI Consultancies, LLC | 2026-09-15 |
| K260879 | 4DM | INVIA, LLC | 2026-09-10 |
| K261795 | Quicktome Software Suite | Omniscient Neurotechnology Pty, Ltd. | 2026-09-10 |
| K251417 | ReVISION 2 | Argus Cognitive, Inc. | 2026-09-09 |
| K260525 | NextMR Spine | MRI2CT, Inc. | 2026-09-04 |
| K260811 | Heartvue.Proton | Heartvue.ai, Inc. | 2026-08-26 |
| K261595 | Ceevra Reveal 4 | Ceevra, Inc. | 2026-08-25 |