Lumisys, Lumiscan 20
FDA 510(k) K953964 · Lumisys, Inc.
510(k) numberK953964
Submission
- Device name
- Lumisys, Lumiscan 20
- Applicant
- Lumisys, Inc.
San Leandro, CA, US - Received
- August 22, 1995
- Decision date
- September 18, 1995
- 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 |
|---|---|---|
| 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 |
| K933129 | Lumiscan 50LMA · Traditional | 10/07/1993SE |
| 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 Lumisys, Lumiscan 20 cleared by the FDA?
Lumisys, Lumiscan 20 (K953964) received a 510(k) decision of Substantially Equivalent on September 18, 1995, 27 days after the submission was received.
What is the product code of K953964?
The FDA product code is LMA – Digitizer, Image, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2030.