510(k) K971382

PRONE BREAST POSITIONING BOARD, MODEL #37-018 by Victoreen, Inc. — Product Code IYE

K971382 is an FDA 510(k) premarket notification submitted by Victoreen, Inc. for the device "PRONE BREAST POSITIONING BOARD, MODEL #37-018". The FDA issued a decision of Substantially Equivalent on June 6, 1997. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Victoreen, Inc. has at least 10 other 510(k) clearances on record.