Prism Software Program
510(k) K904978
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904978 | Date25 Feb 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Software Program Used W/Prism Products
- 510(k) Number
- FDA Product Code
- DXK
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a software program classified as an echocardiograph (product code DXK) under FDA regulation 870.2330. It is designed to function in conjunction with Prism Imaging’s hardware products, enabling advanced cardiovascular imaging analysis and interpretation. The software supports multimodality imaging studies, facilitating physician workflows for diagnostic evaluation in echocardiography.
The software is supplied as a standalone program intended for use with Prism Imaging’s imaging systems, requiring no additional sterility measures. It is classified as a Class II medical device under FDA regulations and holds a FDA 510(k) clearance (K904978) for substantial equivalence in cardiovascular applications. No specific single-use or reusable designation is provided, though its integration with imaging hardware dictates its operational context. No MRI safety or size specifications are noted in the regulatory data.
Other devices from Prism Imaging, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Prism Imaging echocardiograph software designed for?
The Prism Imaging echocardiograph software is designed to function alongside Prism Imaging’s hardware products to enable advanced cardiovascular imaging analysis and interpretation. It supports multimodality imaging studies, helping physicians streamline diagnostic evaluations in echocardiography. The software is specifically cleared by the FDA for cardiovascular applications under product code DXK, ensuring its use is tailored to cardiac assessments.
How is the software supplied and what sterility measures apply?
The software is supplied as a standalone program and is not intended for direct patient contact, so no additional sterility measures are required. It is meant to be used exclusively with Prism Imaging’s imaging systems, where its functionality is integrated into the hardware’s operational context. Since it is not a physical device that interacts with patients, sterility is not applicable.
Is the software single-use or reusable?
The software itself is not designated as single-use or reusable in the regulatory data. Its operational context is tied to Prism Imaging’s imaging hardware, meaning it is intended for repeated use within clinical settings as long as the hardware systems it pairs with remain functional and compliant. The software’s lifecycle aligns with the hardware’s maintenance and updates.
What regulatory clearance does the software hold?
The software holds an FDA 510(k) clearance (K904978) for substantial equivalence in cardiovascular applications. This clearance confirms that the software meets FDA standards for Class II medical devices under regulation 870.2330, specifically for echocardiograph use. The decision was made by the Cardiovascular (CV) Advisory Committee in 1991, ensuring its suitability for diagnostic imaging in cardiac care.
Does the software have any size or MRI safety specifications?
The regulatory data for this software does not include any specific size specifications or MRI safety information. Since it is a standalone program designed for use with imaging hardware, its operational constraints are determined by the hardware systems it integrates with rather than standalone physical dimensions or MRI compatibility. Always verify compatibility with the specific imaging system in use.