Deerfield Imaging, Inc.

FDA Regulatory Profile

Summary

Total Recalls
21
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0934-2022Class IITrumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFFebruary 17, 2022
Z-2584-2021Class IIOperating room table - Product Usage: intended for use during diagnostic examinations, radiologic prAugust 25, 2021
Z-2586-2021Class IIOperating room table - Product Usage: intended for use during diagnostic examinations, radiologic prAugust 25, 2021
Z-2585-2021Class IIOperating room table - Product Usage: intended for use during diagnostic examinations, radiologic prAugust 25, 2021
Z-0762-2020Class IIiMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite November 26, 2019
Z-0163-2020Class IIIMRIS MR/X-ray head fixation device, Model HFD200June 26, 2019
Z-0647-2019Class IIIMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 11November 6, 2018
Z-0645-2019Class IIIMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110November 6, 2018
Z-0646-2019Class IIIMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ONovember 6, 2018
Z-0648-2019Class IIIMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - ProduNovember 6, 2018
Z-1645-2018Class IIIMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditioApril 4, 2018
Z-1264-2018Class IIIMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114February 23, 2018
Z-1218-2018Class IIIMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic February 23, 2018
Z-1263-2018Class IIIMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600February 23, 2018
Z-1265-2018Class IIIMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600February 23, 2018
Z-1217-2018Class IIIMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic February 23, 2018
Z-1266-2018Class IIIMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600February 23, 2018
Z-0975-2018Class IIIMRIS ORT100 Table, Part Number 110470-000February 20, 2018
Z-0976-2018Class IIIMRIS T2X Table, Part Number 109682-600February 20, 2018
Z-3211-2017Class IIIMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screwAugust 14, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K240157InVision™ 1.5 Surgical TheatreFebruary 15, 2024
K212367IMRIS iMRI 3T VAugust 23, 2021