5 devices · 1 company · 2020 to 2025

Volta Medical: AI-enabled devices on FDA's list

5 devices from Volta Medical, 2020 to 2025, from 1 company across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 5 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Every device, newest decision first

Volta Medical · 5 devices
DecisionDevicePanelProduct codeFDA
Volta AF-Xplorer IIK251518 · 510(k)CardiovascularDQKdatabase entry
Volta AF-XplorerK243812 · 510(k)CardiovascularDQKdatabase entry
Volta AF-XplorerK232616 · 510(k)CardiovascularDQKdatabase entry
VX1+K223516 · 510(k)CardiovascularDQKdatabase entry
VX1K201298 · 510(k)CardiovascularDQKdatabase entry

Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.

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Every device here is authorized for a stated use. See a record read against what it must prove, on your own file.

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