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FDA 510(k)

LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART

K-Number: K100096 · 2010-04-22

ApplicantIntegra Radionics, Inc.
Decision Date2010-04-22
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART is the device name listed in this FDA 510(k) record. The listed applicant is Integra Radionics, Inc.. It received FDA 510(k) clearance on 2010-04-22 under 510(k) number K100096. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART?

LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART is a medical device that received FDA 510(k) clearance on 2010-04-22. The listed applicant is Integra Radionics, Inc.. The 510(k) number is K100096.

When did LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART receive FDA 510(k) clearance?

LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART received FDA 510(k) clearance on 2010-04-22, under 510(k) number K100096.

Who is the listed applicant for LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART?

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

What is the FDA product code for LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART?

The FDA product code for LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART is IYE.

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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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