510(k) K163253
- Device
- Arterys Cardio DL
- Applicant
- ARTERYS INC.
- 510(k) number
- K163253
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-01-05
- Date received
- 2016-11-18
- Regulation
- 892.2050
- Classification name
- System, Image Processing, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Golnaz Moeini
- Address
- 51 Federal St., Suite 305 San Francisco CA US 94107 94107
FDA Registration Numbers
- 3033527241
- 3007120336
- 3011213614
- 3011501361
- 1000314502
- 3008481104
- 3030228551
- 3019544554
- 3014954414
- 3033527273
- 3000190675
- 1125622
- 3038187462
- 3008596921
- 3011240766
- 3012916784
- 3004485675
- 3013844297
- 3011114764
- 3010287737
- 3007545404
- 3021637148
- 3010342382
- 3008110533
- 3010533307
- 1047843
- 8030128
- 2936485
- 3024820186
- 3009302839
- 3009196578
- 3024040179
- 1043653
- 3015537315
- 3009185973
- 3019006180
- 1644408
- 3001675293
- 3043840131
- 3004497354
- 3042175844
- 3013041594
- 2031966
- 1032347
- 3000976525
- 3027408258
- 9680215
- 3014132130
- 9610482
- 3003769120
- 3015276088
- 3003998208
- 3008012314
- 3005778458
- 3017991646
- 3029915548
- 3010160527
- 3033527770
- 3014232555
- 3030979155
- 3009140718
- 3001722928
- 3005406110
- 9613347
- 3008142630
- 3024185724
- 3005914761
- 9617978
- 3011307657
- 3012075008
- 3005517190
- 3011221522
- 3010197287
- 3030228575
- 3002619337
- 3009149931
- 3023266032
- 3024438491
- 3004120479
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B664CVM20 | Arterys Cardio DL | Arterys Inc. | 2018-06-23 |
| 08624310003104 | Arterys Cardio DL | Arterys Inc. | 2017-03-15 |
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| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026-02-23 |
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Legacy Summary
summary
FDA Review
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