510(k) K211459
- Device
- Syngo.via MI WorkFlows, Scenium, Syngo MBF
- Applicant
- Siemens Medical Solutions USA, Inc.
- 510(k) number
- K211459
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-06-10
- Date received
- 2021-05-11
- Regulation
- 892.2050
- Classification name
- Automated Radiological Image Processing Software
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Clayton Ginn
- Address
- 810 Innovation Dr. Knoxville TN US 37932 37932
FDA Registration Numbers#
- 8043836
- 3019844085
- 3016461002
- 8022257
- 3013410552
- 3019541896
- 3033527283
- 3008693672
- 3013552417
- 3017210169
- 3003594449
- 1000432246
- 9710090
- 3020928588
- 9616047
- 3040335643
- 3015516266
- 9617277
- 3030655434
- 3010952312
- 3001722928
- 3015612252
- 3042243683
- 3038177848
- 3042902406
- 3007630531
- 3033508292
- 3019216
- 3015425142
- 3017167291
- 3012981490
- 3010885402
- 3029915548
- 3017426576
- 3045078825
- 3014146081
- 3025110425
- 3042248552
- 9616251
- 2936485
- 3002619337
- 3045817397
- 3012761544
- 3006209933
- 9611343
- 3033527273
- 3002808157
- 3021561977
- 3012747207
- 3042940623
- 3042175844
- 3044737887
- 3021887566
- 3042470731
- 3014665798
- 3010398867
- 3017058304
- 3039211310
- 3005930550
- 1226773
- 3014678441
- 3012987001
- 3027977501
- 8043933
- 3014745562
- 3010656400
- 3029923647
- 3017976149
- 3017489096
- 3018302800
- 3025602618
- 3004977335
- 1836549
- 3045521711
- 3010102386
- 3024972425
- 3015218501
- 3027986210
- 1423253
Source Documents#
Other 510(k) Records For Product Code QIH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252571 | mdprostate | Mediaire GmbH | 2026-08-07 |
| K253902 | RealGUIDE | 3DIEMME SRL | 2026-08-04 |
| K253835 | Affinity | Hermes Medical Solutions AB | 2026-07-31 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases