Mammography Color Display DP-M3010
FDA 510(k) clearance K143718 · decided 2015-01-22
Clearance details
- K-number
- K143718
- Device name
- Mammography Color Display DP-M3010
- Applicant
- Canon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-12-29
- Decision date
- 2015-01-22
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- PGY
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hiratsuka-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.