Identifiers
- 510(k) Number
- K994210 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Inturis Suite is a medical imaging system intended for the display and reading of cardiac angiographic images stored on a compact disk (CD) or an image server. It is a software system that provides functionality for viewing and analyzing medical images. The system is designed to assist healthcare professionals in interpreting cardiac angiographic data.
The Inturis Suite is supplied on a CD-ROM containing the installation program, executable files, DLL files, and a readme file. It is a non-sterile device that can be used multiple times. The system has received FDA 510(k) clearance with the product code LLZ and authorization number K994210. It is manufactured by Philips Medical Systems, Inc.
Frequently asked questions
What is the Inturis Suite used for?
The Inturis Suite is a medical imaging software system designed for healthcare professionals to display, read, and analyze cardiac angiographic images stored on a compact disk or an image server. It assists in interpreting cardiac angiographic data.
How is the Inturis Suite supplied?
The Inturis Suite is supplied on a CD-ROM containing the installation program, executable files, DLL files, and a readme file. It is a non-sterile device that can be used multiple times.
What regulatory approvals does the Inturis Suite have?
The Inturis Suite has received FDA 510(k) clearance with product code LLZ and authorization number K994210. It was determined to be substantially equivalent through the traditional clearance process.
Who manufactures the Inturis Suite?
The Inturis Suite is manufactured by Philips Medical Systems, Inc., located at 710 Bridgeport Ave., Shelton, CT 06484. The contact person for this device is Frank Gianelli.
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: Philips Inturis Suite - allmed.wiki, Inturis Suite 510 (k) FDA Premarket Notification K994210 PHILIPS ..., fda.innolitics.com, FDA Browser - Cleared 510 (K) - INTURIS SUITE (K994210), Philips Healthcare | DICOM - PACS
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K994210 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems, Inc.
Sources (1)
- FDA 510(k) K994210 24 fields · synced Sep 28, 2026