ColorPoint 1720 Medical Imagers and Video Capture Box CX-1000 Series
by Seiko Instruments USA, Inc.
510(k) K991282
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991282 | Date30 Jun 1999 | 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- Withdrawn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
- LMC
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2040
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The ColorPoint 1720 Medical Imagers and Video Capture Box CX-1000 Series is a Camera, Multi Format, Radiological, designed to capture and convert electronic signals from medical imaging modalities into hard-copy output. This device facilitates diagnostic imaging by enabling the recording and archiving of radiographic images for clinical review and patient records. It supports multiple imaging formats, ensuring compatibility with various radiological systems.
This device is intended for use in radiology settings and has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device. Supplied as a reusable system, it requires proper maintenance and calibration to ensure accurate image capture and reproduction. The CX-1000 Series operates within regulatory standards outlined under 21 CFR 892.2040, with multiple registration numbers listed for compliance tracking. No specific sterility or MRI safety information is provided in the available data.
Other devices from Seiko Instruments USA, Inc.
Questions
AI-generated answers, 20 Sep 2026
What is the primary purpose of the ColorPoint 1720 Medical Imagers and Video Capture Box CX-1000 Series in a clinical setting?
The ColorPoint 1720 CX-1000 Series is designed to capture electronic signals from radiological imaging systems and convert them into hard-copy output. This allows clinicians to record, archive, and review radiographic images for diagnostic purposes and patient records, ensuring compatibility with multiple imaging formats commonly used in radiology.
Is the ColorPoint 1720 CX-1000 Series intended for single-use or reusable applications?
The device is supplied as a reusable system, meaning it is built for repeated use in radiology settings. However, proper maintenance, calibration, and adherence to manufacturer guidelines are required to ensure accurate and reliable image capture and reproduction over time.
What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?
The ColorPoint 1720 CX-1000 Series received FDA clearance under the Traditional 510(k) pathway and is classified as a Class II medical device. This classification aligns with its role in capturing and archiving radiographic images for diagnostic use in radiology.
Does this device require any special handling or storage conditions?
The provided data does not specify sterility requirements or special storage conditions for the ColorPoint 1720 CX-1000 Series. However, since it is a reusable system, it should be stored in a clean, controlled environment to prevent contamination and ensure proper functionality. Regular maintenance and calibration are also recommended to maintain performance.
How can I verify the regulatory compliance of this device?
The device holds multiple registration numbers (e.g., 3001722928, 3015276088) and operates under 21 CFR 892.2040. These identifiers can be used to track compliance and verify its status in the FDA’s database. The product code (LMC) and advisory committee (Radiology) further categorize its regulatory filing.