All-Pro 2010

FDA 510(k) K001321 · All-Pro Imaging Corp.

Substantially Equivalent

510(k) numberK001321

Submission

Device name
All-Pro 2010
Applicant
All-Pro Imaging Corp.
Hicksville, NY, US
Received
April 26, 2000
Decision date
May 16, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

Other 510(k)s with product code IXW

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K111167Xtender Film Processor, Sprint Film Processor Model Xtender Model SprintIXW · Traditional Velopex International, Inc.08/18/2011SE
K093503Intrax Film ProcessorIXW · Traditional Velopex International, Inc.01/06/2010SE
K091628Optimax, Compact 2, Optimax 2010, EcomaxIXW · Traditional Protec GmbH & Co. KG08/21/2009SE
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

More from Tek Marketing, Inc.

510(k)DeviceDecision
K001314MedscopeHEX · Traditional 07/25/2000SE
K991435Aii-Pro 100 Plus and All-Pro 200IXW · Traditional 05/20/1999SE
K911291All-Pro 100IXW · Traditional 07/03/1991SE

Questions and answers

When was All-Pro 2010 cleared by the FDA?

All-Pro 2010 (K001321) received a 510(k) decision of Substantially Equivalent on May 16, 2000, 20 days after the submission was received.

What is the product code of K001321?

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