SleepImage System 2
SleepImage System 2 is a Class II device made by MyCardio, LLC, cleared under FDA 510(k) K182618 on 14 Aug 2019 and listed in FDA GUDID since 10 Nov 2023 (UDI-DI B315SLEEPIMAGESYSTEMD8), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB315SLEEPIMAGESYSTEMD8 | Date10 Nov 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182618 | Date14 Aug 2019 | StatusActive |
Official records
- FDA 510(k) database K182618
Across registries
- FDA 510(k) K182618 decided 14 Aug 2019 Active
- FDA GUDID UDI-DI B315SLEEPIMAGESYSTEMD8 listed 10 Nov 2023 Listed
Timeline
- Cleared FDA 510(k) K182618
- Listed FDA GUDID B315SLEEPIMAGESYSTEMD8
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SleepImage System
- Generic name
- Sleep disorder interpretive software, professional-only
- Model / reference
- 2
- Primary DI / UDI-DI
- B315SLEEPIMAGESYSTEMD8
- 510(k) Number
- FDA product code
- MNR
- GMDN term
- Sleep disorder interpretive software, professional-only
- Device class
- Class II
- Regulation number
- 868.2375
- GUDID distribution status
- In Commercial Distribution
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