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FDA 510(k)

CTXX85

K-Number: K182147 · 2018-09-07

ApplicantAnalogic Corporation
Decision Date2018-09-07
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CTXX85 is a medical device manufactured by Analogic Corporation. It received FDA 510(k) clearance on 2018-09-07 under approval 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. It is manufactured by Analogic Corporation. The 510(k) number is K182147.

When was CTXX85 approved by the FDA?

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

What company makes CTXX85?

CTXX85 is manufactured by Analogic Corporation.

What is the FDA product code for CTXX85?

The FDA product code for CTXX85 is JAK.

Other Devices by Analogic Corporation

K161342Sonic Window K172058CT6485, CT12885 K201231CTxx85 CT Scanner

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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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