Cpivision Digital Imaging System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K061173 FDA 510(k)
- FDA Product Code
- OWB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1650 FDA 510(k)
- Regulation Number
- 892.1650 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CPIVISION DIGITAL IMAGING SYSTEM is an Interventional Fluoroscopic X-Ray System, as defined by its device name and classification. It is a Class II medical device used in radiology for imaging purposes.
The system was cleared by the FDA through the 510(k) pathway under K-number K061173 on June 9, 2006, with a determination of Substantial Equivalence. It is manufactured by Communications & Power Industries Canada Inc. and is supplied as a non-sterile, reusable system intended for use in clinical radiology settings.
Frequently asked questions
What is the CPIVISION DIGITAL IMAGING SYSTEM used for?
The CPIVISION DIGITAL IMAGING SYSTEM is an Interventional Fluoroscopic X-Ray System used in radiology for imaging purposes, as defined by its device name and classification as a Class II medical device.
Is the CPIVISION DIGITAL IMAGING SYSTEM sterile or non-sterile, and is it single-use or reusable?
The system is supplied as a non-sterile, reusable system intended for use in clinical radiology settings, meaning it is designed for multiple uses after appropriate cleaning and is not provided in a sterile condition.
How was the CPIVISION DIGITAL IMAGING SYSTEM authorized for market release?
The system was cleared by the FDA through the 510(k) pathway under K-number K061173 on June 9, 2006, with a determination of Substantial Equivalence, indicating it met the requirements for substantial equivalence to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: & Cpivision Digital Imaging - allmed.wiki, PDF CPIVision2.indd - cpii.com, HaRi · COMMUNICATIONS & POWER INDUSTRIES CANADA INC., CPIVISION DIGITAL IMAGING SYSTEM 510 (k) K061173 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061173 | Class II | Active |
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Manufacturer
- Manufacturer
- Communications & Power Industries Canada Inc
- FDA Applicant
- Communications & Power Industries Canada, Inc.
Sources (1)
- FDA 510(k) K061173 24 fields · synced Sep 26, 2026