21-00149 Technical Questionnaire Addedum.docx

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PORTABLE, LOW-FIELD MAGNETIC RESONANCE IMAGING (MRI) SYSTEM
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1333ND21QNB680081
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NB686080-21-00149 Brand Name Justifcation Redacted.pdf PDF
1333ND21QNB680081 RFQ.pdf PDF

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TECHNICAL QUESTIONNAIRE ADDENDUM

PORTABLE LOW-FIELD MAGNETIC RESONANCE IMAGING (MRI) SYSTEM

1. Please detail any components of the system or software that are not FDA-approved.

2. If the Picture archiving and communication system (PACS) is operated locally, does it need to be a dedicated server, or could it be a computer used for multiple purposes?

3. What method is used to encrypt any data stored on the MRI system itself?

4. If the MRI system is connected to a PACS system, are images stored on the MRI system? If yes, for how long?

5. If a device is used to operate the MRI system, are images stored on that device en route to the PACS system?

6. When system updates are performed remotely (if possible), what data, if any, is sent to the vendor? Please provide examples of these files.

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