Breast Riser CX MAC000109
by Quality Electrodynamics LLC
Breast Riser CX MAC000109 is a Class I device made by Quality Electrodynamics LLC, cleared under FDA 510(k) K142002 on 22 Aug 2014 and listed in FDA GUDID since 9 Dec 2016 (UDI-DI 00814848020195), 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 | Number00814848020195 | Date9 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142002 | Date22 Aug 2014 | StatusActive |
Official records
- AccessGUDID record 00814848020195
- FDA 510(k) database K142002
Across registries
- FDA 510(k) K142002 decided 22 Aug 2014 Active
- FDA GUDID UDI-DI 00814848020195 listed 9 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K142002
- Listed FDA GUDID 00814848020195
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Breast Riser CX
- Generic name
- Radiological breast positioner, non-wearable
- Model / reference
- MAC000109
- Primary DI / UDI-DI
- 00814848020195
- 510(k) Number
- FDA product code
- CCX
- GMDN term
- Radiological breast positioner, non-wearable
- Device class
- Class I
- Regulation number
- 868.6820
- GUDID distribution status
- In Commercial Distribution
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