Cleared Abbreviated

K050190 - APOLLO

K050190 is an FDA 510(k) clearance for APOLLO, manufactured by Villa Sistemi Medicali S.P.A.. The device is a Class 2 Radiology device with product code KXJ cleared through the Abbreviated 510(k) pathway after a 57-day FDA review.

K050190 · Villa Sistemi Medicali S.P.A. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
57d
Days
Class 2
Risk

K050190 is an FDA 510(k) clearance for the APOLLO. Classified as Table, Radiologic (product code KXJ), Class II - Special Controls.

Submitted by Villa Sistemi Medicali S.P.A. (Franklin Park, US). The FDA issued a Cleared decision on March 25, 2005 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Villa Sistemi Medicali S.P.A. devices

FDA 510(k) Submission Details - K050190

510(k) Number K050190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2005
Decision Date March 25, 2005
Days to Decision 57 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Standards-based clearance path.

KXJ Device Classification - Class 2, Special Controls

Product Code KXJ Table, Radiologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 - KXJ Table, Radiologic

All 17
Devices cleared under the same product code (KXJ) and FDA review panel - the closest regulatory comparables to K050190.
RADIOGRAPHIC ITT TABLE
K963905 · X-Ray Technologies, Inc. · Nov 1996
XRT 400
K955414 · Wuestec Medical, Inc. · Jul 1996
CARBON FIBER COUCH INSERT
K950068 · Medtec, Inc. · Apr 1995
SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5
K940696 · Philips Medical Systems North America, Inc. · Mar 1994
ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES
K931724 · Continental X-Ray Corp. · Jun 1993
CAG-02A
K922098 · Toshiba America Medical Systems, In.C · Jul 1992