Cleared Traditional

K000380 - FOTOMASTER

K000380 is the FDA 510(k) clearance for FOTOMASTER by Hamilton Thorne Research. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K000380 · Hamilton Thorne Research · Radiology device
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May 2000
Decision
86d
Days
Class 2
Risk

K000380 is an FDA 510(k) clearance for the FOTOMASTER. 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 Hamilton Thorne Research (Beverly, US). The FDA issued a Cleared decision on May 3, 2000 after a review of 86 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 Hamilton Thorne Research devices

Submission Details

510(k) Number K000380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2000
Decision Date May 03, 2000
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
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 Peers - LLZ System, Image Processing, Radiological

All 1091
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K000380.
3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A
K002424 · Toshiba America Medical Systems, In.C · Oct 2000
VITREA 2, VERSION 2.1
K002519 · Vital Images, Inc. · Oct 2000
MEDLINK DIAGNOSTIC OFFLINE WORKSTATION
K002144 · Advanced Technology Laboratories, Inc. · Sep 2000
BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY
K000292 · Barco N.V. · Mar 2000
BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY
K000293 · Barco N.V. · Mar 2000
MFCD 118
K000291 · Barco N.V. · Mar 2000