SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P010025/S017 · decided 2009-12-23
Approval details
- PMA number
- P010025
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Hologic, Inc.
- Date received
- 2009-11-05
- Decision date
- 2009-12-23
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Danbury, CT
- Statement
- APPROVAL FOR THE SELENIA DIMENSION 2D FFDM TO BE USED IN A MOBILEENVIRONMENT WITH THE FOLLOWING DESIGN CHANGES:1) ACQUISITION STATION:A) THE ACQUISITION STATION MONITOR WILL BE MOUNTED ON A FIXED MOUNT MECHANISM THAT ALLOWS POSITIONING OF THE MONITOR VIA A SPRING LOADED LOCKING DEVICE. THE MOBILE SYSTEM MONITOR CAN BE FIXED MOUNTED ON THE LEFT,RIGHT OR CENTER POSITION.B) THE KEYBOARD TRAY HAS BEEN SECURED WITH A SPRING LOADED LATCHING MECHANISM TO PREVENT MOVEMENT DURING TRANSPORT.C) THE BAR COD
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