DeepRhythmAI - The DeepRhythmAI (DRAI) is a cloud-based software - MEDICALGORITHMICS S A

Duns Number:522657576

Device Description: The DeepRhythmAI (DRAI) is a cloud-based software for automated analysis of ECG data. It u The DeepRhythmAI (DRAI) is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration. The main component of DeepRhythmAI is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review. DeepRhythmAI can be integrated into medical devices.

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More Product Details

Catalog Number

-

Brand Name

DeepRhythmAI

Version/Model Number

Type: DRAI

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K210822

Product Code Details

Product Code

DPS

Product Code Name

Electrocardiograph

Device Record Status

Public Device Record Key

b1f49c65-d9f2-4599-bc04-78d4f5a26b4b

Public Version Date

August 15, 2022

Public Version Number

1

DI Record Publish Date

August 05, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICALGORITHMICS S A" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16