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 |