DS CASSETTE
FDA 510(k) clearance K053173 · decided 2005-12-15
Clearance details
- K-number
- K053173
- Device name
- DS CASSETTE
- Applicant
- Konica Minolta Medical & Graphic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-14
- Decision date
- 2005-12-15
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- IXA
- Device class
- 2
- Regulation number
- 892.1850
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mie-Ken, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.