Lumiscan 50
FDA 510(k) K933129 · Lumisys, Inc.
510(k) numberK933129
Submission
- Device name
- Lumiscan 50
- Applicant
- Lumisys, Inc.
San Leandro, CA, US - Received
- June 28, 1993
- Decision date
- October 7, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Pyramid Medical, Inc.
| 510(k) | Device | Decision |
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| K980809 | Lumiscan 135 Phosphor Plate Digitizer/Lumisys 135 EraserLMA · Traditional | 05/11/1998SE |
| K980213 | DI-2000LMA · Traditional | 03/17/1998SE |
| K953371 | Lumisys Dicom TooklitLMD · Traditional | 10/18/1995SE |
| K953964 | Lumisys, Lumiscan 20LMA · Traditional | 09/18/1995SE |
| K902347 | Compact Laser Imager, Model CLI-100LMC · Traditional | 03/04/1991SE |
| K901423 | Digital Image Scanner, Model DIS-1000LMA · Traditional | 04/30/1990SE |
Questions and answers
When was Lumiscan 50 cleared by the FDA?
Lumiscan 50 (K933129) received a 510(k) decision of Substantially Equivalent on October 7, 1993, 101 days after the submission was received.
What is the product code of K933129?
The FDA product code is LMA – Digitizer, Image, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2030.