510(k) K260525
- Device
- NextMR Spine
- Applicant
- MRI2CT, Inc.
- 510(k) number
- K260525
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-04
- Date received
- 2026-02-17
- 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
- Aveim Amossi
- Address
- 2093 Philadelphia Pike #9769 Claymont DE US 19703 19703
FDA Registration Numbers#
- 3010398867
- 3015169361
- 3010703925
- 3024820186
- 3029937167
- 9680269
- 8043933
- 3021907554
- 3011015597
- 3022719380
- 3002808157
- 3000976525
- 3018064242
- 3031569584
- 3015612252
- 3015173183
- 3021637148
- 2126677
- 3017167291
- 3015276088
- 3003899230
- 3012981490
- 9610482
- 9613445
- 3029915548
- 2936485
- 3014665798
- 1651903
- 3014809646
- 3032008018
- 3039211310
- 3025603301
- 9614698
- 3004977335
- 8020021
- 3001675293
- 3030446846
- 3002619337
- 1826555
- 9710090
- 3014938447
- 3017894900
- 3025110425
- 3019844085
- 3029900829
- 3019216
- 3015173173
- 3023245
- 3033527273
- 3042243683
- 3017426576
- 3035455070
- 3010119782
- 3006209933
- 3011063460
- 3036725840
- 3021032044
- 9616251
- 3015537315
- 3011205675
- 1000432246
- 3006985147
- 3011763071
- 3018094310
- 3011189058
- 3008729547
- 9612283
- 3016579137
- 3011950073
- 3016585383
- 3044776706
- 3045817397
- 3042940623
- 3027160711
- 3014146081
- 3007194257
- 3015516266
- 3017487805
- 3023217364
Source Documents#
Other 510(k) Records For Product Code QIH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260811 | Heartvue.Proton | Heartvue.ai, Inc. | 2026-08-26 |
| K261595 | Ceevra Reveal 4 | Ceevra, Inc. | 2026-08-25 |
| K260584 | BoneMRI | Mriguidance B.V. | 2026-08-21 |
| K262127 | DS Core CBCT Anatomy | Dentsply Sirona | 2026-08-21 |
| K261641 | Lower Limb AI (LLAI) | AI Planning Logic, Inc. | 2026-08-18 |
| 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 |