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FDA 510(k)

CURA 16; ScintCare CT16

K-Number: K173076 · 2018-10-04

ApplicantFmi Medical Systems, Inc.
Decision Date2018-10-04
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CURA 16; ScintCare CT16 is a medical device manufactured by Fmi Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-10-04 under approval number K173076. 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 CURA 16; ScintCare CT16?

CURA 16; ScintCare CT16 is a medical device that received FDA 510(k) clearance on 2018-10-04. It is manufactured by Fmi Medical Systems, Inc.. The 510(k) number is K173076.

When was CURA 16; ScintCare CT16 approved by the FDA?

CURA 16; ScintCare CT16 received FDA 510(k) clearance on 2018-10-04, under approval number K173076.

What company makes CURA 16; ScintCare CT16?

CURA 16; ScintCare CT16 is manufactured by Fmi Medical Systems, Inc..

What is the FDA product code for CURA 16; ScintCare CT16?

The FDA product code for CURA 16; ScintCare CT16 is JAK.

Other Devices by Fmi Medical Systems, Inc.

K192590CURA 778

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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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