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#
- 3003899230
- 3013844297
- 3021637148
- 3017426576
- 3030598283
- 3005369776
- 3008284470
- 3035455070
- 8043933
- 3047842058
- 8030233
- 3032367
- 3017297314
- 3020331900
- 3013306229
- 3025430791
- 3010157088
- 2936485
- 3011063460
- 3007630531
- 3008729547
- 3015276088
- 3004141078
- 3042955884
- 3016759115
- 3015763655
- 3043625056
- 3032807464
- 3016824824
- 3036756245
- 9611992
- 3044737887
- 8043836
- 2518586
- 3018302800
- 3034527804
- 3009758186
- 3027977501
- 3028006458
- 3021027284
- 1836549
- 9710602
- 3002619337
- 3011015597
- 3011763071
- 3011950073
- 3017233423
- 3007301305
- 2532090
- 3033527283
- 3027160711
- 3018733944
- 3045817397
- 3021907554
- 3022973841
- 3032008018
- 3007545404
- 3021561977
- 3007675959
- 3042928350
- 3043494619
- 3030446846
- 1226773
- 3025602618
- 3024972425
- 3025343020
- 3005930550
- 3016461002
- 2126677
- 3019878658
- 3042940623
- 3024820186
- 8022257
- 3005403518
- 1000432246
- 3015509619
- 3035373446
- 3010703925
- 3012987001
Source Documents#
Other 510(k) Records For Product Code QIH#
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|---|---|---|---|
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| K260584 | BoneMRI | Mriguidance B.V. | 2026-08-21 |
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| K261641 | Lower Limb AI (LLAI) | AI Planning Logic, Inc. | 2026-08-18 |
| K253794 | Prostate Core | Lucida Medical, Ltd. | 2026-08-10 |
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| 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 |
| K260206 | SkeletonPlanner | UPlanner B.V. - Presurgeo | 2026-07-15 |