Scan Room Module 78
by Neocoil, LLC
Scan Room Module 78 is a Class II device made by Neocoil, LLC, cleared under FDA 510(k) K173409 on 16 Feb 2018 and listed in FDA GUDID since 26 Apr 2018 (UDI-DI 00856181003787), active as of 22 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 | Number00856181003787 | Date26 Apr 2018 | StatusListed |
| United States | FDA 510(k) | NumberK173409 | Date16 Feb 2018 | StatusActive |
Official records
- AccessGUDID record 00856181003787
- FDA 510(k) database K173409
Across registries
- FDA 510(k) K173409 decided 16 Feb 2018 Active
- FDA GUDID UDI-DI 00856181003787 listed 26 Apr 2018 Listed
Timeline
- Cleared FDA 510(k) K173409
- Listed FDA GUDID 00856181003787
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Scan Room Module
- Generic name
- Headphones
- Model / reference
- 78
- Primary DI / UDI-DI
- 00856181003787
- 510(k) Number
- FDA product code
- LNH
- GMDN term
- Headphones
- Device class
- Class II
- Regulation number
- 892.1000
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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