Identifiers
- 510(k) Number
- K880822 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PICS-2000 is a multidimensional image processing and viewing system designed for radiology applications. It functions as an independent, standalone unit that accepts image data from various scanners via a magnetic tape reader, processes the data, and displays high-quality images on a 19-inch color monitor.
The PICS-2000 is supplied as a reusable, non-sterile medical device intended for use in radiology departments. It operates in a clinical setting and requires appropriate storage conditions to maintain functionality. The device holds an FDA 510(k) clearance under K-number K880822, granted in 1988, and is classified under product code JAK.
Frequently asked questions
What is the primary purpose of the PICS-2000 system in a radiology department?
The PICS-2000 is designed to process and display high-quality medical images from various scanners. It functions as a standalone system that reads image data from magnetic tapes, enhances and reconstructs the images, and presents them on a 19-inch color monitor, improving diagnostic clarity for radiologists.
Is the PICS-2000 intended for single-use or reusable applications, and how should it be stored?
The PICS-2000 is explicitly described as a reusable, non-sterile medical device. Since it operates in a clinical radiology setting, it should be stored in a clean, controlled environment to preserve its functionality and prevent damage, following manufacturer guidelines for optimal performance.
What type of regulatory clearance does the PICS-2000 hold, and under which committee was it reviewed?
The PICS-2000 holds an FDA 510(k) clearance under K-number K880822, granted in 1988. It was reviewed by the Radiology (RA) Advisory Committee and classified under product code JAK, indicating its intended use in radiology imaging systems.
How does the PICS-2000 receive image data for processing?
The system accepts image data from external scanners via a magnetic tape reader, allowing it to process and display images from multiple sources in a radiology workflow. This integration enables seamless workflow between imaging hardware and the PICS-2000’s display capabilities.
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: K880822 - PICS-2000 | FDA 510 (k) | Philips Medical Systems, Inc., Philips Healthcare Pics-2000 - allmed.wiki, PDF Philips Medical Systems - flipphillips.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K880822 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Medical Systems, Inc.
Sources (1)
- FDA 510(k) K880822 24 fields · synced Sep 19, 2026