FDA-Device2018-12-26Class II
IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.
Deerfield Imaging, Inc.
Hazard
Table may drift in the roll position while in use
Sold states
Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.
Affected count
27 units
Manufactured in
5101 Shady Oak Rd S, Minnetonka, MN, United States
Products
IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0646-2019Don't want to check this manually?
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