510(k) K213544
- Device
- TOMTEC-ARENA
- Applicant
- TOMTEC Imaging Systems GmbH
- 510(k) number
- K213544
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-01-06
- Date received
- 2021-11-08
- 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
- Marc Bergenthal
- Address
- Freisinger Strasse 9 Unterschleissheim DE 85716 85716
FDA Registration Numbers#
- 9611343
- 3025602618
- 8043933
- 3042852277
- 3016819165
- 3029923647
- 3007301305
- 9616251
- 3031915908
- 3014809646
- 3021907554
- 3013306229
- 3013410552
- 3017487805
- 3024972425
- 9610482
- 3030412475
- 3010885402
- 1826555
- 3033508292
- 1000432246
- 3006209933
- 2126677
- 3015276088
- 3015509619
- 3007734888
- 3024820186
- 3021637148
- 3045817397
- 3017102960
- 3007545404
- 1836549
- 3014678441
- 3028006458
- 3011763071
- 3033527283
- 3023245
- 3033527241
- 3033527273
- 9680825
- 3047842058
- 3019541896
- 3016585383
- 2518586
- 3014665798
- 3036502204
- 3003768277
- 3042175844
- 3017426576
- 3011063460
- 9710122
- 3016461002
- 3005225421
- 3018094310
- 3042902406
- 3015612252
- 3017297314
- 3007630531
- 1651903
- 3016965352
- 3019844085
- 3010342382
- 3016579137
- 3015425142
- 3015763655
- 3017173128
- 3014146081
- 3010656400
- 3019544554
- 3010703925
- 3008496839
- 3014132130
- 3035950510
- 8022257
- 3008837339
- 3029900829
- 8030233
- 2936485
- 3035455070
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 |
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