510(k) K260879
- Device
- 4DM
- Applicant
- INVIA, LLC
- 510(k) number
- K260879
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-10
- Date received
- 2026-03-17
- 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
- Edward Ficaro
- Address
- 3025 Boardwalk Dr., Suite 200 Ann Arbor MI US 48108 48108
FDA Registration Numbers#
- 3036502204
- 3005403518
- 1000432246
- 9710090
- 3018094310
- 3028006458
- 3008729547
- 3006165260
- 3025602618
- 3017976149
- 3015169361
- 3017058304
- 3010703925
- 3008837339
- 3003768277
- 3018064242
- 3044776706
- 3015612252
- 3010656400
- 3019541896
- 9680269
- 3042248552
- 3003899230
- 3014310698
- 3018302800
- 1644408
- 3025110425
- 3030088963
- 3031915908
- 3023217364
- 3010398867
- 3011063460
- 3016965352
- 3002808157
- 3004141078
- 3016585383
- 3020703662
- 3006209933
- 3019878658
- 3008284470
- 3009196578
- 3005225421
- 9710645
- 3030655434
- 3033509898
- 3030089065
- 3019216
- 2936485
- 3014146081
- 3035386366
- 3020928588
- 3045521711
- 3001722928
- 3006985147
- 3023245
- 3011015597
- 3012987001
- 3013306229
- 3019544554
- 3042175844
- 3017489096
- 3034527804
- 3004977335
- 3009731198
- 2126677
- 3035455070
- 3021032044
- 3012747207
- 3017936978
- 3024972425
- 3036756245
- 3013844297
- 3027347389
- 3007675959
- 3022973841
- 8020021
- 3015173173
- 3013757696
- 3004972322
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 |
| 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 |
| K260584 | BoneMRI | Mriguidance B.V. | 2026-08-21 |