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The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2…

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EAN 9355529000033 · RESONANCE HEALTH ANALYSIS SERVICES PTY LTD · Medical Device

Identity

Name
The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 1.5T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.
Barcode (EAN/GTIN)
9355529000033
Brand / Manufacturer
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
Category
Medical Device
GS1 Prefix
Australia (GS1 prefix 935)

Regulated substances (3)

About these substances

Plain-language summary of each regulated substance found above, drawn from public regulatory data.

Nickel (soluble compounds) (CAS 7440-02-0)

Nickel (soluble compounds) refers to forms of the metal nickel that can dissolve in water, such as nickel sulfate, nickel chloride, and nickel acetate. These substances are commonly used in metal plating, batteries, and as catalysts in chemical manufacturing. They are regulated under California's Proposition 65 because scientific studies have shown that exposure to soluble nickel compounds can increase the risk of cancer. The California Office of Environmental Health Hazard Assessment (OEHHA) lists these compounds as causing cancer, based on evidence from animal and human studies. This means that products containing these chemicals must carry a warning label in California. You might encounter nickel in jewelry, coins, or stainless steel, but soluble forms are more likely in industrial settings or certain consumer goods like some batteries. This summary draws on public regulatory data; the linked source is authoritative. Source: California OEHHA Proposition 65 List (https://oehha.ca.gov/proposition-65/proposition-65-list).

Nickel compounds (CAS 7440-02-0)

Nickel compounds are a group of substances that include nickel metal, nickel sulfate, nickel chloride, and nickel acetate. You might encounter them in everyday items like stainless steel cookware, jewelry, coins, batteries, and some industrial products. The World Health Organization's International Agency for Research on Cancer (IARC) classifies nickel compounds as Group 1, meaning they are carcinogenic to humans based on strong evidence from studies of exposed workers. This regulation exists because inhaling certain nickel compounds in workplaces like refineries or plating shops has been linked to an increased risk of lung cancer. IARC's evaluation helps guide safety measures to limit exposure, especially in occupational settings. For the general public, typical contact through consumer products is not considered a major concern, but the classification highlights the importance of controlling industrial emissions and workplace dust. This summary draws on public regulatory data; the linked source is authoritative. Source: WHO IARC Monographs (https://monographs.iarc.who.int/list-of-classifications)

Nickel and its compounds

Nickel is a naturally occurring metal used in many everyday items like stainless steel, jewelry, coins, and electronics. It is also found in some compounds used in industrial processes, such as plating and batteries. Under EU REACH Annex XVII, nickel and its compounds are restricted because they can cause allergic skin reactions in people who are sensitive to it. Prolonged contact with nickel-releasing items, like certain earrings or watch straps, may lead to dermatitis. The restriction limits how much nickel can be released from products that come into direct and prolonged contact with the skin. This helps protect consumers from developing allergies. The European Chemicals Agency (ECHA) oversees these rules. For more details, visit: https://echa.europa.eu/substances-restricted-under-reach. This summary draws on public regulatory data; the linked source is authoritative.

FDA Medical Device Registry

This product is registered as a medical device in the U.S. FDA Global Unique Device Identification Database (GUDID).

Rx Prescription
BrandT1CMR Phantom (1.5T)
ManufacturerRESONANCE HEALTH ANALYSIS SERVICES PTY LTD
DescriptionThe T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 1.5T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.
Modelv1.0
Catalog #-
FDA Product CodeIXG
GMDN Code40636

Source: FDA GUDID (open access, U.S. Federal public domain) · last seen 2026-10-01T07:02:22Z

What we found about this product

A factual report of what public registries and product databases returned for this EAN. We do not authenticate products or issue safety verdicts — we only report what we found.

Identifier checks

Registry scans

Sources scanned: GS1 country prefix · Wikidata brand registry · Open Beauty / Food Facts · USDA FDC Branded Foods · Nudger GTIN dataset · EU Safety Gate (RAPEX) · US CPSC · US FDA recalls · Health Canada Recalls · NHTSA recalls · ECHA SVHC · REACH Annex XVII · EU RoHS · Stockholm POPs · CLP Annex VI · EU Cosmetic Annex II · EU Ecolabel · US ENERGY STAR · US EPA Safer Choice · US FDA GUDID · EU EUDAMED.
Last refreshed: .

About this section. We aggregated what we found across 24 public registries and product databases as of . This is not an authentication, certification, or safety endorsement. Coverage gaps in our source data exist. For definitive verification, please contact the manufacturer or the relevant regulator directly.

Disclaimer. Substance and ingredient information is matched against public government registries (cited above) and may be incomplete or imprecise for a specific batch. This page is informational only and does not constitute medical, legal, or safety advice. For health concerns consult a qualified specialist. For confirmed product safety status refer to the manufacturer and the linked regulatory source.

Provenance

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See also

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