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. Author manuscript; available in PMC: 2009 Apr 1.
Published in final edited form as: Semin Ultrasound CT MR. 2008 Apr;29(2):156–164. doi: 10.1053/j.sult.2007.12.003

Table 1.

The upper limits given in the original and present 510(k) guides.[22, 30]

Original 1985 Present Track 1 Present Track 3
Ispta.3 Isppa.3 Ispta.3 Isppa.3 Ispta.3 MI
Application mW/cm2 W/cm2 mW/cm2 W/cm2 mW/cm2 none
Peripheral vessel 720 65 720 190 720 1.9
Cardiac 430 65 430 190 720 1.9
Fetal imaging* 46 65 94 190 720 1.9
Ophthalmic 17 28 17 28 50 0.23
*

and other general imaging such as pediatric, intra-operative, and cephalic.