Cleared Traditional

Hybrid Viewer (00859873006189) (K241364) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241364 · Hermes Medical Solutions AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
178d
Days
Class 2
Risk

K241364 is an FDA 510(k) clearance for the Hybrid Viewer (00859873006189). Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Hermes Medical Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on November 8, 2024 after a review of 178 days - an extended review 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: 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 Hermes Medical Solutions AB devices

Submission Details

510(k) Number K241364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2024
Decision Date November 08, 2024
Days to Decision 178 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
71d slower than avg
Panel avg: 107d · This submission: 178d
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 177
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K241364.
Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
K241266 · Raysolution Healthcare Co., Ltd. · Jan 2025
Aurora
K243605 · Ge Medical Systems Israel, Functional Imaging · Jan 2025
uMI Panvivo (uMI Panvivo)
K243538 · Shanghai United Imaging Healthcare Co., Ltd. · Dec 2024
Symbia Pro.specta Q3 (11364751)
K243186 · Siemens Medical Solutions USA, Inc. · Oct 2024
uMI Panorama
K241585 · Shanghai United Imaging Healthcare Co., Ltd. · Aug 2024
uMI Panvivo
K241596 · Shanghai United Imaging Healthcare Co., Ltd. · Aug 2024