LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
FDA 510(k) clearance K040884 · decided 2004-04-23
Clearance details
- K-number
- K040884
- Device name
- LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-05
- Decision date
- 2004-04-23
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- IZH
- Device class
- 2
- Regulation number
- 892.1710
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Danbury, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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