Cleared Traditional

K201807 - ANCORIS

K201807 is the FDA 510(k) clearance for ANCORIS by Miegmbh. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K201807 · Miegmbh · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
57d
Days
Class 2
Risk

K201807 is an FDA 510(k) clearance for the ANCORIS. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Miegmbh (Seth, DE). The FDA issued a Cleared decision on August 27, 2020 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Miegmbh devices

Submission Details

510(k) Number K201807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2020
Decision Date August 27, 2020
Days to Decision 57 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
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 242
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K201807.
Affinity
K202882 · Hermes Medical Solutions AB · Dec 2020
SIR-Spheres Microspheres Activity Calculator (SMAC)
K202392 · Sirtex Medical US Holdings, Inc. · Oct 2020
Cartesion Prime, PCD-1000A, V10.7
K202349 · Canon Medical Systems Corporation · Oct 2020
ImagenSPECT 3.0
K201933 · Cardiovascular Imaging Technologies · Aug 2020
HYPER DLR
K193210 · Shanghai United Imaging Healthcare Co., Ltd. · Aug 2020
Symbia 6.7
K200474 · Siemens Medical Solutions USA, Inc. · Mar 2020