Cleared Traditional

K221955 - Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 (FDA 510(k) Clearance)

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

K221955 · Realcloud Imaging Inc. Dba Realcloud Imaging · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
57d
Days
Class 2
Risk

K221955 is an FDA 510(k) clearance for the Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Realcloud Imaging Inc. Dba Realcloud Imaging (Ames, US). The FDA issued a Cleared decision on August 31, 2022 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 Realcloud Imaging Inc. Dba Realcloud Imaging devices

Submission Details

510(k) Number K221955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2022
Decision Date August 31, 2022
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 MUH System, X-ray, Extraoral Source, Digital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 Consultant

W. Edward Johansen
Ed Johansen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MUH System, X-ray, Extraoral Source, Digital

All 205
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K221955.
SOTA Cloud Smart Sensor (1.5)
K251793 · Sota Cloud Corp. · Mar 2026
EzSensor HD, EzSensor UHD
K252570 · Qpix Solutions, Inc. · Nov 2025
Cocoon Solo (DX-7020s)
K250687 · Dexcowin Global, Inc. · Oct 2025
Digital X-Ray DentiMax Pro Imaging System
K251206 · Dentimax, Inc. · Sep 2025
VistaPano S Ceph 2.0 (VistaPano S Ceph)
K240040 · VATECH Co., Ltd. · Oct 2024
X Sensor (Model: IOS-A15IF, HDI-15DGF)
K242778 · Qpix Solutions, Inc. · Oct 2024