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Sign in to claim this brandCHILI GmbH
US
Last updated May 27, 2026
What CHILI GmbH makes
CHILI GmbH manufactures radiology picture archiving and communication system (PACS) workstations, designed for storing, retrieving, and displaying medical imaging data in healthcare settings. These systems facilitate the digital management of images such as X-rays, MRIs, and CT scans, enabling efficient workflows for radiologists and clinicians.
The company’s PACS workstations are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The portfolio is regulated in the United States, where the manufacturer is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does CHILI GmbH manufacture?
CHILI GmbH specializes in radiology picture archiving and communication system (PACS) workstations. These devices are designed to store, retrieve, and display medical imaging data—such as X-rays, MRIs, and CT scans—in healthcare environments. Their focus is on digital workflow solutions for radiologists and clinicians.
Where is CHILI GmbH based, and where are its devices regulated?
CHILI GmbH is based in the United States. Its devices are regulated in the U.S., where they are classified as Class II medical devices under FDA guidelines. This classification applies to moderate-risk devices that require special controls to ensure safety and effectiveness.
Are CHILI GmbH’s devices listed in any regulatory databases?
Yes, CHILI GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices by assigning them a standardized identifier, ensuring transparency and traceability for regulatory and market surveillance purposes.
How are CHILI GmbH’s PACS workstations classified under FDA regulations?
CHILI GmbH’s PACS workstations fall under the FDA’s Class II device classification. This category includes devices that generally pose moderate risks and require additional controls beyond general controls (like good manufacturing practices) to ensure their safety and performance. The classification is determined based on factors like the device’s intended use and potential risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 331736095
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Chili Pacs | 4.56 | FDA UDI | Class II | Active |
| Chili Pacs | 4.72.0 | FDA UDI | Class II | Active |
| Chili Pacs | 4.66.0 | FDA UDI | Class II | Active |
| Chili Pacs | 4.64.0 | FDA UDI | Class II | Active |
| Chili Pacs | 4.52 | FDA UDI | Class II | Active |
| Chili Pacs | 4.68.0 | FDA UDI | Class II | Active |
| Chili Pacs | 4.58 | FDA UDI | Class II | Active |
| Chili Pacs | 4.74.0 | FDA UDI | Class II | Active |
| CHILI GmbH | 4.60 | FDA UDI | Class II | Active |
| Chili Pacs | 4.70.0 | FDA UDI | Class II | Active |
| Chili Pacs | 4.54 | FDA UDI | Class II | Active |
| Chili Pacs | 4.62.0 | FDA UDI | Class II | Active |
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