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FDA 510(k)

ALARA IMAGING SYSTEM

K-Number: K955643 · 1996-03-01

ApplicantDenoptix, Inc.
Decision Date1996-03-01
Product CodeEGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALARA IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Denoptix, Inc.. It received FDA 510(k) clearance on 1996-03-01 under 510(k) number K955643. The device is classified under product code EGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALARA IMAGING SYSTEM?

ALARA IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-01. The listed applicant is Denoptix, Inc.. The 510(k) number is K955643.

When did ALARA IMAGING SYSTEM receive FDA 510(k) clearance?

ALARA IMAGING SYSTEM received FDA 510(k) clearance on 1996-03-01, under 510(k) number K955643.

Who is the listed applicant for ALARA IMAGING SYSTEM?

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

What is the FDA product code for ALARA IMAGING SYSTEM?

The FDA product code for ALARA IMAGING SYSTEM is EGY.

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Related Devices (Code: EGY)

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Official Source

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

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