Cleared Traditional

K000557 - MEDVIZER PACS, MODEL RELEASE 2000

K000557 is an FDA 510(k) clearance for MEDVIZER PACS, manufactured by Vitel Net. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K000557 · Vitel Net · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
66d
Days
Class 2
Risk

K000557 is an FDA 510(k) clearance for the MEDVIZER PACS, MODEL RELEASE 2000. 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 Vitel Net (Mclean, US). The FDA issued a Cleared decision on April 24, 2000 after a review of 66 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.

FDA 510(k) Submission Details - K000557

510(k) Number K000557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2000
Decision Date April 24, 2000
Days to Decision 66 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
41d faster than avg
Panel avg: 107d · This submission: 66d
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 2293
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K000557.
EINSTEIN PROCESSING AND REVIEW WORKSTATION
K000395 · Ge Medical Systems F.I. Haifa · May 2000
IDS5 IMAGE DISPLAY SYSTEM
K001140 · Sectra AB · May 2000
REMOTE FETAL MEDICINE ULTRASOUND SYSTEM
K000443 · R4 Telemedicine, Inc. · Apr 2000
PACSSTATION
K000448 · Fernandez Industries, Inc. · Apr 2000
VIEW NT
K000474 · Electromed Intl., Ltd. · Apr 2000
BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY
K000292 · Barco N.V. · Mar 2000
K000557 · MEDVIZER PACS, MODEL RELEASE 2000
Download PDF FDA Summary Vitel Net