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Digitizer, Image, Radiological

FDA product code LMA · Class 2 · Radiology

20
Registered devices
5
Adverse events
2
Recalls
61
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2019-09-25Brainlab AGThe 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,
2005-03-30Konica 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

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.