510(k) K182727
K182727 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "Trident HD Specimen Radiography System". The FDA issued a decision of Substantially Equivalent on January 10, 2019. The device falls under product code MWP (Cabinet, X-Ray System), a Class II device regulated under 21 CFR 892.1680. Hologic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 2019
- Date Received
- September 28, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cabinet, X-Ray System
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type