Micromate™ Navi+

FDA 510(k) K230130 · Isys Medizintechnik GmbH

Substantially Equivalent

510(k) numberK230130

Submission

Device name
Micromate™ Navi+
Applicant
Isys Medizintechnik GmbH
Kitzbuehel, AT
Received
January 17, 2023
Decision date
October 10, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAK – System, X-Ray, Tomography, Computed
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Specialty
Radiology

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Questions and answers

When was Micromate™ Navi+ cleared by the FDA?

Micromate™ Navi+ (K230130) received a 510(k) decision of Substantially Equivalent on October 10, 2023, 266 days after the submission was received.

What is the product code of K230130?

The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.