Intrax Film Processor

FDA 510(k) K093503 · Velopex International, Inc.

Substantially Equivalent

510(k) numberK093503

Submission

Device name
Intrax Film Processor
Applicant
Velopex International, Inc.
St. Cloud, FL, US
Received
November 12, 2009
Decision date
January 6, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IXW – Processor, Radiographic-Film, Automatic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1900
Specialty
Radiology

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K111167Xtender Film Processor, Sprint Film Processor Model Xtender Model SprintIXW · Traditional Velopex International, Inc.08/18/2011SE
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K024342Radiographic Film Processor, Models XP400 and XP1000IXW · Traditional Daito Co., Ltd.04/23/2003SE
K023825Film Processor, Model Life Ray Pro 2500IXW · Abbreviated S.A.I.E.P. S.R.L.02/12/2003SE
K023801Film Processor, Model Life Ray Pro 1000IXW · Abbreviated S.A.I.E.P. S.R.L.02/12/2003SE
K023613AX200 Automatic X-Ray Film Processor, Model 6586.036IXW · Traditional Alphatek Corp.01/23/2003SE
K022154Level 356 X-Ray Film Processor, Models MD & Md-DIXW · Traditional Fischer Industries, Inc.09/30/2002SE
K002640Freedom Automatic Film ProcessorIXW · Abbreviated J. Morita USA, Inc.11/08/2000SE
K002404Micro-Max, Model 319IXW · Traditional Tek Marketing, Inc.08/30/2000SE
K001321All-Pro 2010IXW · Traditional All-Pro Imaging Corp.05/16/2000SE

More from All-Pro Imaging Corp.

510(k)DeviceDecision
K111167Xtender Film Processor, Sprint Film Processor Model Xtender Model SprintIXW · Traditional 08/18/2011SE
K024105Velopex Aquacut Fluid Abrasion UnitKOJ · Traditional 10/09/2003SE

Questions and answers

When was Intrax Film Processor cleared by the FDA?

Intrax Film Processor (K093503) received a 510(k) decision of Substantially Equivalent on January 6, 2010, 55 days after the submission was received.

What is the product code of K093503?

The FDA product code is IXW – Processor, Radiographic-Film, Automatic, a Class II (moderate risk) device regulated under 21 CFR 892.1900.