510(k) K980809
- Device
- LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER
- Applicant
- LUMISYS, INC.
- 510(k) number
- K980809
- Product code
- LMA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-05-11
- Date received
- 1998-03-03
- Regulation
- 892.2030
- Classification name
- Digitizer, Image, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- GARY J ALLSENBROOK
- Address
- 16303 Panoramic Way San Leandro CA US 94578 94578
FDA Registration Numbers
- 3010461419
- 3026970882
- 3039346136
- 3007766685
- 3015976667
- 3009717300
- 1316463
- 3008596921
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Legacy Summary
summary
FDA Review
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