Cleared Traditional

K081215 - VOLUMINA

K081215 is an FDA 510(k) clearance for VOLUMINA, manufactured by Kjaya Medical, LLC. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K081215 · Kjaya Medical, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
118d
Days
Class 2
Risk

K081215 is an FDA 510(k) clearance for the VOLUMINA. 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 Kjaya Medical, LLC (Stamford, US). The FDA issued a Cleared decision on August 26, 2008 after a review of 118 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K081215

510(k) Number K081215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2008
Decision Date August 26, 2008
Days to Decision 118 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 107d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LLZ Device Classification - Class 2, Special Controls

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

Intertek Testing Services

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 2268
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K081215.
AMICAS PACS, VERSION 6.0
K082144 · Amicas, Inc. · Sep 2008
STEREOS WORKSTATION
K080529 · Biospace Med · Aug 2008
DSA 2000EX
K082341 · Eigen, LLC · Aug 2008
CENTRICITY PACS IW
K082318 · Ge Healthcare Dynamic Imaging Solutions · Aug 2008
C-INSIGHT
K081672 · Mazor Surgical Technologies , Ltd. · Aug 2008
EDGE PACS
K081752 · Ashva Technologies, Pvt., Ltd. · Aug 2008
K081215 · VOLUMINA
Download PDF FDA Summary Kjaya Medical, LLC