Cleared Traditional

K092204 - PMD VIEWER

K092204 is an FDA 510(k) clearance for PMD VIEWER, manufactured by Spencer Technologies. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K092204 · Spencer Technologies · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
78d
Days
Class 2
Risk

K092204 is an FDA 510(k) clearance for the PMD VIEWER. 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 Spencer Technologies (Seattle, US). The FDA issued a Cleared decision on October 8, 2009 after a review of 78 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 Spencer Technologies devices

FDA 510(k) Submission Details - K092204

510(k) Number K092204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2009
Decision Date October 08, 2009
Days to Decision 78 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 107d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - LLZ System, Image Processing, Radiological

All 1325
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K092204.
INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP
K092639 · GE Medical Systems SCS · Dec 2009
COLOR LCD MONITOR, MODEL RADIFORCE MX241W
K092741 · Eizo Nanao Corporation · Nov 2009
INTEGRATED REGISTRATION
K093234 · GE Medical Systems SCS · Oct 2009
ABVS WORKPLACE
K092067 · Siemens AG Medical Solutions · Sep 2009
SYNGO.X
K092519 · Siemens AG Medical Solutions · Aug 2009
BEYONDIMAGE WORKSTATION
K092235 · Neusoft Medical Systems Co., Ltd. · Aug 2009