XPress BCD Breast Compression Device
FDA 510(k) clearance K163388 · decided 2017-07-19
Clearance details
- K-number
- K163388
- Device name
- XPress BCD Breast Compression Device
- Applicant
- Xpress Bcd, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-12-02
- Decision date
- 2017-07-19
- Days to decision
- 229 days
- Clearance type
- Traditional
- Product code
- POY
- Device class
- 2
- Regulation number
- 892.1710
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Frederick, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.