510(k) K131433

ISYS 1 (U.S),ACCESSORY, NON-STERILE by Isys Medizintechnik GmbH — Product Code JAK

K131433 is an FDA 510(k) premarket notification submitted by Isys Medizintechnik GmbH for the device "ISYS 1 (U.S),ACCESSORY, NON-STERILE". The FDA issued a decision of Substantially Equivalent on March 11, 2014. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Isys Medizintechnik GmbH has at least 2 other 510(k) clearances on record.