Cleared Traditional

K000630 - MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM

K000630 is an FDA 510(k) clearance for MODELS PRIAM (FAMILY OF DEVICES) DIGITA..., manufactured by Hopkins Imaging Systems, Inc.. 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.

K000630 · Hopkins Imaging Systems, Inc. · Radiology device
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May 2000
Decision
78d
Days
Class 2
Risk

K000630 is an FDA 510(k) clearance for the MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM. 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 Hopkins Imaging Systems, Inc. (Duarte, US). The FDA issued a Cleared decision on May 12, 2000 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 Hopkins Imaging Systems, Inc. devices

FDA 510(k) Submission Details - K000630

510(k) Number K000630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2000
Decision Date May 12, 2000
Days to Decision 78 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
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 1776
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