19-INCH (48CM) Color LCD Monitor CDL1904A
510(k) K051403
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051403 | Date14 Jul 2005 | 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- Withdrawn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, 24 Sep 2026
The 19-Inch (48cm) Color LCD Monitor CDL1904A is a medical imaging display peripheral. It is designed to function in conjunction with Picture Archiving and Communication Systems (PACS) for medical imaging applications.
This device is manufactured by Totoku Electric Co., Ltd. and has received FDA 510(k) clearance under the Traditional pathway. It is classified as a radiology device under product code LLZ.
Other devices from Totoku Electric Co., Ltd.
Questions
AI-generated answers, 24 Sep 2026
What is the primary purpose of the Totoku CDL1904A monitor?
The CDL1904A is a medical imaging display peripheral specifically designed to function in conjunction with Picture Archiving and Communication Systems (PACS) to support medical imaging applications.
What is the regulatory status of this monitor?
This device has received FDA 510(k) clearance under the Traditional pathway. It is officially classified as a radiology device under product code LLZ, indicating it has been found substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of the CDL1904A display?
The device is manufactured by Totoku Electric Co., Ltd., located in Nagano, Japan. The company submitted the device for review, resulting in a decision of substantial equivalence in July 2005.