Lumisys Lumiscan 20
510(k) K953964
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK953964 | Date18 Sep 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LMA
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2030
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Lumisys Lumiscan 20 is a radiological image digitizer classified as a Class II medical device. It is designed to function within radiology settings to convert medical images into digital formats.
This device has received FDA 510(k) clearance under the identifier K953964. It is manufactured by Lumisys, Inc. and is regulated under the product code LMA.
Other devices from Lumisys, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the primary function of the Lumisys Lumiscan 20?
The Lumiscan 20 is a radiological image digitizer. Its purpose is to convert traditional medical images into digital formats, allowing them to be integrated into digital workflows within radiology departments.
What is the regulatory classification of this device?
The Lumisys Lumiscan 20 is classified as a Class II medical device. It has received FDA 510(k) clearance under the identifier K953964, confirming it is substantially equivalent to other devices in the radiology category.
Which medical specialty is this digitizer intended for?
This device is intended for use within the radiology specialty. It is regulated under product code LMA, which corresponds to radiological image digitizers used to support diagnostic imaging processes.