SleepImage System

GUDID B315SLEEPIMAGESYSTEMD8

The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage System analyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected during sleep, that is intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management for children, adolescents and adults. The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing. The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.

MYCARDIO LLC

Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only

• Primary Device ID: B315SLEEPIMAGESYSTEMD8
• NIH Device Record Key: 97fc2e9d-ac7d-4954-9996-6dcde766c3be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SleepImage System
• Version Model Number: 2
• Company DUNS: 964500776
• Company Name: MYCARDIO LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B315SLEEPIMAGESYSTEMD8 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182618

FDA Product Code

• MNR: Ventilatory Effort Recorder

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-20
• Device Publish Date: 2023-11-10

Devices Manufactured by MYCARDIO LLC

• B315SLEEPIMAGESYSTEMD8 - SleepImage System: 2023-11-20The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage System analyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected during sleep, that is intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management for children, adolescents and adults. The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing. The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.
• B315SLEEPIMAGESYSTEMD8 - SleepImage System: 2023-11-20 The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage System analyzes, dis
• B315SLEEPIMAGECOM0 - SleepImage: 2018-07-06 Web based software