Identifiers
- 510(k) Number
- K042935 FDA 510(k)
- FDA Product Code
- KPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1200 FDA 510(k)
- Regulation Number
- 892.1200 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body.
It is supplied as a Class II system under FDA 510(k) clearance K042935, granted on November 9, 2004, and is used in radiology settings. The device is manufactured by Philips Medical Systems (Cleveland), Inc. and is intended for diagnostic imaging applications.
Frequently asked questions
What is the GEMINI GXL used for?
The GEMINI GXL is a diagnostic imaging system used in radiology settings to produce cross-sectional images of the body by combining Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) subsystems for diagnostic imaging applications.
How is the GEMINI GXL supplied and installed?
The GEMINI GXL is supplied as a system for fixed or mobile installations, meaning it can be permanently installed in a facility or configured for mobile use depending on clinical needs and site requirements.
What regulatory pathway was used for the GEMINI GXL?
The GEMINI GXL received FDA 510(k) clearance under number K042935 on November 9, 2004, and was determined to be substantially equivalent to a legally marketed predicate device under the traditional review pathway.
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: GEMINI GXL by PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | FDA 510 (k ..., GEMINI GXL (K042935) - FDA 510 (k), Philips Gemini GXL - allmed.wiki, Gemini GXL Installation Manual 15.2m | PDF | Gamma Ray | Login - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042935 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
Sources (1)
- FDA 510(k) K042935 24 fields · synced Sep 22, 2026