Cleared Traditional

K163122 - NobelClinician

K163122 is the FDA 510(k) clearance for NobelClinician by Nobel Biocare AB. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K163122 · Nobel Biocare AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
84d
Days
Class 2
Risk

K163122 is an FDA 510(k) clearance for the NobelClinician, DTX Studio implant. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on January 31, 2017 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Nobel Biocare AB devices

Submission Details

510(k) Number K163122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2016
Decision Date January 31, 2017
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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

Nobel Biocare USA, LLC
CHALEMAGNE CHUA

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 - LLZ System, Image Processing, Radiological

All 1127
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K163122.
FDX Console (DR-ID300CL) Software
K170451 · Fujifilm Medical Systems U.S.A, Inc. · Mar 2017
Lung Nodule Assessment and Comparison Option (LNA)
K162484 · Philips Medical Systems Nederland B.V. · Feb 2017
syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology
K163294 · Siemens Medical Solutions USA, Inc. · Feb 2017
Multi Modality Viewer
K163574 · Vital Images, Inc. · Jan 2017
EzDent-i
K163533 · Ewoosoft Co., Ltd. · Jan 2017
syngo.via MI Workflows
K163421 · Siemens Medical Solutions USA, Inc. · Jan 2017