510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Imalux Corporation

Cleveland, OH, US

Imalux Corporation appears in FDA device records in Cleveland, OH. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 2 510(k) clearances for Imalux Corporation in 2004.

Clearances by year, as a table
510(k) clearance decisions for Imalux Corporation, by decision year
YearClearances
20042
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K042894IMALUX NIRIS IMAGING SYSTEMNQQSubstantially Equivalent
K041077IMALUX OCT PROBE GUIDEKKXSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0934-2012Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX Corporation, Cleveland, OH The Niris Imaging System probe is used with the Niris Imaging System. The Niris Imaging System employs Optical Coherence Tomography (OCT), which can be used to construct high spatial resolution. The probe, is attached to the Imaging Console, and is used to direct light to and from the patient tissue. A small electromechanical scanning mechanism in the probe moves the optical beam laterally across the tissue surface while simultaneously acquiring in-depth backscattering profile at each lateral position. The probe is not labeled or sold as sterile.During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain