DI-2000
FDA 510(k) clearance K980213 · decided 1998-03-17
Clearance details
- K-number
- K980213
- Device name
- DI-2000
- Applicant
- Lumisys, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-09
- Decision date
- 1998-03-17
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- LMA
- Device class
- 2
- Regulation number
- 892.2030
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.