Cleared Traditional

K230130 - Micromate Navi+

K230130 is an FDA 510(k) clearance for Micromate Navi+, manufactured by Isys Medizintechnik GmbH. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K230130 · Isys Medizintechnik GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
266d
Days
Class 2
Risk

K230130 is an FDA 510(k) clearance for the Micromate™ Navi+. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Isys Medizintechnik GmbH (Kitzbuehel, AT). The FDA issued a Cleared decision on October 10, 2023 after a review of 266 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Isys Medizintechnik GmbH devices

FDA 510(k) Submission Details - K230130

510(k) Number K230130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2023
Decision Date October 10, 2023
Days to Decision 266 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 107d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 635
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K230130.
SpotLight/SpotLight Duo (with DLIR option)
K230370 · Arineta , Ltd. · Oct 2023
Scenaria View 4.2
K231574 · Fujifilm Healthcare Americas Corporation · Oct 2023
NeuViz 128 Multi-Slice CT Scanner System
K230220 · Neusoft Medical Systems Co., Ltd. · Oct 2023
Aquilion Serve (TSX-307A/1) V1.3
K231281 · Canon Medical Systems Corporation · Sep 2023
uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis
K230162 · Shanghai United Imaging Healthcare Co., Ltd. · Aug 2023
Open Rib
K223261 · Canon Medical Informatics, Inc. · Jul 2023