Identity
- Trade Name
- SleepImage System FDA UDI
- Generic Name
- Sleep disorder interpretive software, professional-only FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 2 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B315SLEEPIMAGESYSTEMD8 FDA UDI
- 510(k) Number
- K182618 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Sleep disorder interpretive software, professional-only FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sleep disorder interpretive software, professional-only
SleepImage System by MyCardio, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- MyCardio, LLC
Sources (1)
- FDA UDI 97fc2e9d-ac7d-4954-9996-6dcde766c3be 34 fields · synced May 30, 2026