510(k) K203744
- Device
- Arterys MICA
- Applicant
- Arterys Inc.
- 510(k) number
- K203744
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-14
- Date received
- 2020-12-22
- 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
- Sharon Cholowsky
- Address
- 51 Federal St., Suite 305 San Francisco CA US 94107 94107
FDA Registration Numbers#
- 3014310698
- 3039211310
- 3015516266
- 3005403518
- 3030446846
- 3005383085
- 3009077524
- 3036756245
- 3011763071
- 3024820186
- 1826555
- 2032350
- 3000976525
- 1226773
- 3017425832
- 3012987001
- 3009731198
- 3003594449
- 3012747207
- 3007734888
- 3042852277
- 3000126629
- 3014678441
- 9616251
- 3010952312
- 3042902406
- 3042243683
- 3029900829
- 9710645
- 3042928350
- 3014938447
- 9710122
- 3003775006
- 3025602618
- 3006209933
- 3014132130
- 3017936978
- 3007194257
- 2126677
- 3014809646
- 3033508292
- 3035950510
- 3010342382
- 3010102386
- 9680269
- 3008007310
- 3006165260
- 3015218501
- 3017210169
- 3008284470
- 3021970996
- 3030412475
- 3043494619
- 3025343020
- 3014745562
- 3009758186
- 3021637148
- 3004141078
- 3029915548
- 3009196578
- 3033557977
- 3020928588
- 1818910
- 3029937167
- 3013561205
- 3030655434
- 3016579137
- 3033509898
- 3018064242
- 8043836
- 3033527241
- 3044776706
- 3040335643
- 3015276088
- 3031569584
- 3027645731
- 3029923647
- 3033527283
- 3005739655
Source Documents#
Other 510(k) Records For Product Code QIH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260973 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026-07-07 |
| K253628 | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. | 2026-06-29 |
| K253969 | ADAS 3D | Adas3D Medical S.L. | 2026-06-29 |
| K253786 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | 2026-06-25 |
| K260316 | CMN Capillary Function with Oncology Virtual Expert | Cercare Medical A/S | 2026-06-22 |
| K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | 2026-06-18 |
| K253172 | MediAI-OA | Crescom Co., Ltd. | 2026-06-15 |
Legacy Summary#
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
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