UniSyn Molecular Imaging 6-3-1
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231047 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 UniSyn Molecular Imaging 6-3-1 is a molecular imaging agent designed for diagnostic use in radiology. It is classified as a contrast agent intended to enhance visualization of specific molecular targets within the body, aiding in the detection and characterization of pathological conditions.
This device is supplied as a sterile, single-use solution for intravenous administration. It is intended for use in MRI-compatible settings and is authorized under FDA 510K clearance and MDR compliance. The product is supplied in a pre-filled syringe and requires refrigeration prior to use, adhering to standard sterile medical device handling protocols.
Frequently asked questions
What types of pathological conditions can the UniSyn Molecular Imaging (6-3-1) help detect or characterize in the body?
The UniSyn Molecular Imaging (6-3-1) is a contrast agent designed to enhance visualization of specific molecular targets during MRI scans. While the exact pathological conditions it targets are not detailed, its purpose is to improve detection and characterization of abnormalities by highlighting these molecular markers, which can be useful in identifying conditions like tumors or other molecularly distinct pathologies in radiology settings.
How is the UniSyn Molecular Imaging (6-3-1) supplied, and what are the handling requirements before use?
The UniSyn Molecular Imaging (6-3-1) comes as a sterile, single-use solution in a pre-filled syringe, ensuring readiness for immediate intravenous administration. It must be stored refrigerated prior to use, following standard sterile medical device protocols to maintain its integrity and efficacy. This ensures it remains safe for one-time use in MRI-compatible environments.
Is the UniSyn Molecular Imaging (6-3-1) reusable, or is it intended for single-use only?
The UniSyn Molecular Imaging (6-3-1) is explicitly designed for single-use only, as stated in its supply description. This classification aligns with standard sterile medical device practices to prevent contamination and ensure patient safety during administration.
What regulatory pathways has the UniSyn Molecular Imaging (6-3-1) followed for approval, and which committees were involved?
The UniSyn Molecular Imaging (6-3-1) has undergone FDA 510(k) clearance and complies with the Medical Device Regulation (MDR). The device was reviewed by the Radiology (RA) Advisory Committee under the FDA’s traditional clearance process, with a decision code of SESE (Substantially Equivalent) and a product code of LLZ, confirming its equivalence to a predicate device.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231047 | Class II | Active |
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Manufacturer
- Manufacturer
- Convergent Imaging Solutions
Sources (2)
- FDA 510(k) K231047 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026