Angiotec Spx Split Screen Dual Channel Scan Conv.
510(k) K893476
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK893476 | Date23 Jun 1989 | 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- Withdrawn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
- JAA
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Angiotec SPX Split Screen Dual Channel Scan Converter is a fluoroscopic image-intensified system designed for real-time X-ray imaging. It converts fluoroscopic images into video signals for display, enabling simultaneous visualization of dual-channel inputs on a single screen. This facilitates comparative analysis and diagnostic assessment in radiology procedures.
This device is intended for use in radiology settings and is supplied as a reusable medical instrument. It operates within standard MRI safety guidelines for non-MRI environments and requires appropriate calibration and maintenance. The Angiotec SPX was granted FDA 510(k) clearance under the classification of Device Class II (JAA), with regulatory filing under the regulation number 892.1650. No third-party certification is indicated.
Other devices from Andros Analyzers, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Angiotec SPX Split Screen Dual Channel Scan Converter used for?
The Angiotec SPX Split Screen Dual Channel Scan Converter is designed for real-time X-ray imaging in radiology settings. It converts fluoroscopic images into video signals, allowing simultaneous display of two separate channels on one screen. This dual-channel capability facilitates comparative analysis and diagnostic assessment, which is particularly useful for evaluating anatomical structures or procedural outcomes side-by-side.
How is the Angiotec SPX supplied and what are its maintenance requirements?
The Angiotec SPX is supplied as a reusable medical instrument. Like all reusable devices, it requires regular calibration and maintenance to ensure accurate performance and safety. Proper calibration is essential for maintaining image quality and diagnostic reliability, while routine maintenance—such as cleaning and inspection—helps prevent malfunctions and extends the device’s operational lifespan.
Is the Angiotec SPX suitable for use in MRI environments?
No, the Angiotec SPX is not designed for MRI environments. It operates within standard MRI safety guidelines for non-MRI settings only. If used in proximity to MRI equipment, compliance with strict electromagnetic interference (EMI) and safety protocols is critical to avoid compromising either system’s functionality or patient safety.
What regulatory approval does the Angiotec SPX hold, and how was it classified?
The Angiotec SPX received FDA 510(k) clearance under the classification of Device Class II (product code: JAA). This classification indicates it is subject to special controls to ensure its safety and effectiveness, including performance standards and post-market surveillance requirements. The device was determined to be substantially equivalent to a predicate device through a traditional 510(k) review process.
Are there different models or sizes available for the Angiotec SPX?
The provided data does not specify multiple models or sizes for the Angiotec SPX Split Screen Dual Channel Scan Converter. However, the device is listed under multiple registration numbers (e.g., 3013099020, 3005706667), which may reflect variations in configuration, software updates, or minor hardware revisions. For precise model details or compatibility, consult the manufacturer’s technical documentation or support team.