State Shipping Restrictions: 

At the current time, sales cannot be processed for the US states of New York, Kansas, and South Carolina while we await the final approval of state authorities for the CS2400P.

Other Info:

Registration:
The use of X-ray equipment is regulated, and equipment must be registered with authorities.  Please seek guidance from your respective competent authorities to properly register your equipment. 

Hand Portable equipment may require a specific application. (Alabama, Colorado, Delaware, District of Columbia, Indiana, Iowa, Kansas, Kentucky, Minnesota, Mississippi, North Carolina, Nebraska, New Mexico, Nevada, New York, Oregon, South Carolina, Virginia, Washington currently require applications for hand-held x-ray)

Dosimetry & PPE (Personal Protective Equipment e.g. lead apron):
Dosimetry is the recordable measurement of operator x-ray exposure.  Some US States (below) may require dosimetry with hand held x-ray equipment.  Even though doses associated with use are very low, monitoring radiation is a reasonable safeguard for assurance.  Please seek the guidance of your state & local regulators for specific  guidance. Current requirements include:

Operator Dosimeters Only

Alabama, Florida, Louisiana, Maine, Nebraska, North Carolina, Maine, Vermont, Tennessee 

Operator Lead (Pb) Apron* Only: 

Delaware, Indiana, Kansas, Massachusetts, Minnesota, New York City Dept of Health (NYC only) 

Both Dosimeters AND Lead (Pb) Apron* for Operator  

Colorado, Ohio, Kentucky. North Dakota, New Mexico, Nevada, New Hampshire, South Carolina,  

(NOTE: Colorado, New Mexico, Tennessee, Nevada requires Hand + Body dosimeter badges) 

*Typically, 0.25mm lead equivalence minimal with thyroid collar. 

NOTE: While Dosimeters and lead vests are required for some states, dosimeter use, and lead vests can be a valuable tool for any owner to consider as part of proper risk management to reduce liabilities.  

FDA 2579 form (Report of Assembly)
As per guidance from the FDA – The FDA does not consider the receipt of a finished dental hand-held X-ray equipment and “Installation” and no FDA 2579 is required  per federal guidelines (below).

If your state requires an FDA 2579 form to be completed, a form can be provided to the registrant so it can be submitted to the state.

Acceptance Tests (If required) examples: Texas, Minnesota

If your state requires an Equipment Performance Acceptance Test to be completed by prior to use –A state licensed medical physicist can perform this acceptance test

FDA Guidance on 2579 forms (AKA” Reports of Assembly”:

https://www.fda.gov/media/80801/download

QUESTION: Is a report of assembly (FDA 2579) required for the installation of self-contained (mobile, portable, some dental, etc.) systems containing certified components?

ANSWER: It depends. In most cases the answer is yes, the form must be filed. However, there are a few x-ray components or systems, typically limited to portable or hand-held systems, not requiring assembly upon delivery. For such components or systems, the manufacturer designed the system so that it would be operational and compliant upon delivery (i.e., “no assembly required”). If the manufacturer has stated in its product report submitted to the FDA and in its assembler/user information that no assembly or installation is required, then no report of assembly is required. The individual manufacturer is responsible for certifying these systems and reporting the product to FDA. The manufacturer may require the user to perform checks or tests on the system before using the system on patients. Instructions for conducting those checks or tests must be provided to the assembler (in this case, the user). If only checks or tests are required as mentioned above and no actual assembly is required, no report of assembly is needed.

 

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