510(k) K260811
- Device
- Heartvue.Proton
- Applicant
- Heartvue.ai, Inc.
- 510(k) number
- K260811
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-26
- Date received
- 2026-03-12
- 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
- Jeffrey Dendy
- Address
- 1917 Parade Dr. Brentwood TN US 37027 37027
FDA Registration Numbers#
- 9615849
- 3016824824
- 3008007310
- 3017426576
- 2032350
- 3011063460
- 3014146081
- 3035455070
- 9680269
- 9610482
- 3025343020
- 3036502204
- 9616251
- 3044737887
- 3006165260
- 3025602618
- 9614698
- 3031915908
- 3007630531
- 3015509619
- 3017489096
- 3004977335
- 3005403518
- 3012981490
- 3015173183
- 3015612252
- 3042928350
- 3025603301
- 9710122
- 3019216
- 3017976149
- 2936485
- 3011015597
- 3018064242
- 3029923647
- 3015537315
- 3021637148
- 1226773
- 3013561205
- 3005930550
- 3017840913
- 3032807464
- 3030446846
- 3045817397
- 3020331900
- 3010952312
- 3015276088
- 3008729547
- 3014938447
- 9710602
- 9612283
- 3010885402
- 3042248552
- 3024812789
- 9613445
- 2532090
- 3021561977
- 3027645731
- 3003768277
- 3016446349
- 3035950510
- 3014132130
- 3033527283
- 2518586
- 1836549
- 3022973841
- 3017058304
- 3025430791
- 3005383085
- 3023217364
- 2134213
- 3017167291
- 3023245
- 3014310698
- 3019844085
- 3021887566
- 3036725840
- 3027986210
- 3014745562
- 3036495186
Source Documents#
Other 510(k) Records For Product Code QIH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |