CFR

15.513—Technical requirements for medical imaging systems.

(a) The UWB bandwidth of an imaging system operating under the provisions of this section must be contained between 3100 MHz and 10,600 MHz.

(b) Operation under the provisions of this section is limited to medical imaging systems used at the direction of, or under the supervision of, a licensed health care practitioner. The operation of imaging systems under this section requires coordination, as detailed in § 15.525.

(c) A medical imaging system shall contain a manually operated switch that causes the transmitter to cease operation within 10 seconds of being released by the operator. In lieu of a switch located on the imaging system, it is permissible to operate an imaging system by remote control provided the imaging system ceases transmission within 10 seconds of the remote switch being released by the operator.

(d) The radiated emissions at or below 960 MHz from a device operating under the provisions of this section shall not exceed the emission levels in § 15.209. The radiated emissions above 960 MHz from a device operating under the provisions of this section shall not exceed the following average limits when measured using a resolution bandwidth of 1 MHz:

Frequency in MHz	EIRP in dBm
960-1610	−65.3
1610-1990	−53.3
011990-3100	−51.3
3100-10600	−41.3
Above 10600	−51.3

(e) In addition to the radiated emission limits specified in the table in paragraph (d) of this section, UWB transmitters operating under the provisions of this section shall not exceed the following average limits when measured using a resolution bandwidth of no less than 1 kHz:

Frequency in MHz	EIRP in dBm
1164-1240	−75.3
1559-1610	−75.3

(f) There is a limit on the peak level of the emissions contained within a 50 MHz bandwidth centered on the frequency at which the highest radiated emission occurs, fM. That limit is 0 dBm EIRP. It is acceptable to employ a different resolution bandwidth, and a correspondingly different peak emission limit, following the procedures described in § 15.521.

[68 FR 19751, Apr. 22, 2003, as amended at 72 FR 63823, Nov. 13, 2007]

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