Cleared Special

K190420 - NDOHD High Definition Imaging System (N...

K190420 is the FDA 510(k) clearance for NDOHD High Definition Imaging System (N... by Altaravision, Inc.. It is a Class 2 General & Plastic Surgery device (product code LLZ) cleared through the Special 510(k) pathway after a 53-day FDA review.

K190420 · Altaravision, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
53d
Days
Class 2
Risk

K190420 is an FDA 510(k) clearance for the NDOHD High Definition Imaging System (NDOHD). 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 Altaravision, Inc. (Apex, US). The FDA issued a Cleared decision on April 15, 2019 after a review of 53 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 892.2050 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 Altaravision, Inc. devices

Submission Details

510(k) Number K190420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2019
Decision Date April 15, 2019
Days to Decision 53 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Modification to existing cleared device.

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 General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

MethodSense, Inc.
Rita King

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 1056
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K190420.
Brainlab Elements Image Fusion Angio
K190042 · Brainlab AG · Apr 2019
Ez3D-i/E3
K190791 · Ewoosoft Co., Ltd. · Apr 2019
Lung Vision System
K183593 · Bodyvision Medical , Ltd. · Apr 2019
InstaRISPACS / InstaZFP / InstaMobi v5.0
K182572 · Meddiff Technologies Pvt. , Ltd. · Apr 2019
DBSWIN and VISTAEASY Imaging Software
K190629 · Durr Dental SE · Apr 2019
Thoracic VCAR with GSI Pulmonary Perfusion
K183210 · GE Medical Systems SCS · Mar 2019