3600

IcRco, Inc. · Model SF · UDI-DI 00854810007212

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510(k) clearances

Adverse events

Recalls

Facilities

Description

A compact, single-plate small format computed radiography (CR) scanner designed for general radiography, orthopedics, and mobile imaging. Features a patented True Flat Scan Path to eliminate roller damage and preserve diagnostic image quality.

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.