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FDA 510(k)

MICROSCAN MICROSTEP

K-Number: K111394 · 2011-06-22

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2011-06-22
Product CodeLTT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICROSCAN MICROSTEP is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2011-06-22 under 510(k) number K111394. The device is classified under product code LTT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSCAN MICROSTEP?

MICROSCAN MICROSTEP is a medical device that received FDA 510(k) clearance on 2011-06-22. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K111394.

When did MICROSCAN MICROSTEP receive FDA 510(k) clearance?

MICROSCAN MICROSTEP received FDA 510(k) clearance on 2011-06-22, under 510(k) number K111394.

Who is the listed applicant for MICROSCAN MICROSTEP?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROSCAN MICROSTEP?

The FDA product code for MICROSCAN MICROSTEP is LTT.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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