The following data is part of a premarket notification filed by Angiocloud, Llc with the FDA for Angiocloud Service.
| Device ID | K211713 |
| 510k Number | K211713 |
| Device Name: | AngioCloud Service |
| Classification | System, Image Processing, Radiological |
| Applicant | AngioCloud, LLC 1 Glenlake Parkway, Suite 200 Atlanta, GA 30328 |
| Contact | James Lewis |
| Correspondent | Bahram Parvinian Lighthouse Regulatory Consulting Group, LLC 3 Harrowgate CT Potomac, MD 20854 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-03 |
| Decision Date | 2022-04-28 |