iDR

IcRco, Inc. · Model L · UDI-DI 00854810007113

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The iCRco iDR-L is a cassette-less, stationary digital radiography (DR) long-bone and full-spine imaging system. It features an integrated 17” x 51” (or 14” x 51”) active area scanning detector panel utilizing internal phosphor plate technology. The system is designed for single-exposure, upright, stitch-free long-length skeletal imaging, operating via a motorized vertical wall-mount lift. It incorporates a 16-bit grayscale resolution scan processor and operates via proprietary X-Ray Capture (XC) acquisition software

Recalls

Date	Firm	Reason
2019-09-25	Brainlab AG	The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if us
2005-03-30	Konica Medical Imaging, Inc.	One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three images exactly.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.