Mm/Mma/Color Series Digital Flat Panel Display System
510(k) K073292
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073292 | Date18 Jan 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM is a radiological image processing system. It is classified under product code LLZ and is substantially equivalent to a predicate device as determined by FDA 510(k) clearance.
The device is used in radiology settings and was cleared through the traditional 510(k) pathway. It is manufactured by Heeyoung Co., Ltd. and received FDA clearance on January 18, 2008, under K073292.
Other devices from Heeyoung Co., Ltd.
Questions
AI-generated answers, 25 Sep 2026
What is the MM/MMA/COLOR SERIES Digital Flat Panel Display System used for?
The MM/MMA/COLOR SERIES Digital Flat Panel Display System is a radiological image processing system used in radiology settings to process and display medical images, as indicated by its FDA 510(k) clearance and product code LLZ classification.
How was the MM/MMA/COLOR SERIES Digital Flat Panel Display System cleared for market?
The device received FDA clearance through the traditional 510(k) pathway on January 18, 2008, under K073292, demonstrating substantial equivalence to a predicate device as determined by the FDA.
Who manufactures the MM/MMA/COLOR SERIES Digital Flat Panel Display System and where is it located?
The MM/MMA/COLOR SERIES Digital Flat Panel Display System is manufactured by Heeyoung Co., Ltd., located at 1600 Manchester Way, Denton, TX 76210, United States, as specified in the device authorization records.