FDA 510(k)

CTXX85

K-Number: K182147 · 2018-09-07

Decision Date2018-09-07

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CTXX85 is the device name listed in this FDA 510(k) record. The listed applicant is Analogic Corporation. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K182147. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CTXX85?

CTXX85 is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Analogic Corporation. The 510(k) number is K182147.

When did CTXX85 receive FDA 510(k) clearance?

CTXX85 received FDA 510(k) clearance on 2018-09-07, under 510(k) number K182147.

Who is the listed applicant for CTXX85?

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

What is the FDA product code for CTXX85?

The FDA product code for CTXX85 is JAK.

Other records listing Analogic Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201231CTxx85 CT Scanner K172058CT6485, CT12885 K161342Sonic Window

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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.