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Mikroscan

MIKROSCAN TECHNOLOGIES, INC. · Model SL5 · UDI-DI 00860002275604

510(k) clearances

Adverse events

Recalls

Facilities

Description

The dual mode SL5 system from Mikroscan offers the user two completely separate and distinctly different capabilities in one convenient device. The user selects either the live microscope mode using a fully functional, remotely controlled robotic microscope or a static digital pathology scanner for the creation of whole-slide images*. The protection features of the equipment may be impaired if the device is used in a manner not specified by Mikroscan. *For Research Use Only. Not for use in diagnostic procedures.

Recalls

Date	Firm	Reason
2013-12-20	Zeiss, Carl Inc	Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard Pathology Microscopes due to misalignment of the lambda plate.
2013-05-28	Zeiss, Carl Inc	Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS microscopes (Axio Imager, Axio Scope.A1, Axio Lab.A1) due to Misaligned Full-Wave (Lambd

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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.