510(k) K241696
- Device
- Ortho AI
- Applicant
- Ortho Ai, LLC
- 510(k) number
- K241696
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-02
- Date received
- 2024-06-12
- 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
- No
Applicant Contact#
- Contact
- Jonathan Vigdorchik
- Address
- 155 E. 76th St. Apt. 2h New York NY US 10021 10021
FDA Registration Numbers#
- 3036725840
- 3003775006
- 2936485
- 3023217364
- 8043933
- 3027977501
- 3019844085
- 3017297314
- 3010398867
- 9710602
- 3021637148
- 3017840913
- 3001722928
- 3021970996
- 3042175844
- 1826555
- 3017936978
- 3017489096
- 3003768277
- 3012747207
- 3015763655
- 3045078825
- 3021907554
- 3009731198
- 3014310698
- 3044776706
- 3007194257
- 3013552417
- 1000432246
- 3033527241
- 3027986210
- 3003594449
- 3010102386
- 3030655434
- 3030598283
- 3024812789
- 3017102960
- 3024820186
- 3008496839
- 3016759115
- 3013561205
- 3010885402
- 3012987001
- 3010656400
- 3025110425
- 3011015597
- 3007630531
- 3030412475
- 3035386366
- 3016446349
- 3007734888
- 3029900829
- 3014678441
- 3033557977
- 8022257
- 3020928588
- 3006209933
- 3017167291
- 3036502204
- 8020021
- 3005369776
- 2134213
- 9610482
- 3013868968
- 3045521711
- 3021561977
- 3009196578
- 3038177848
- 3017425832
- 3020703662
- 3019541896
- 1818910
- 3015173173
- 3017233423
- 3010119782
- 3008693672
- 3019216
- 3017426576
- 9613445
- 1651903
Source Documents#
Other 510(k) Records For Product Code QIH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |