Radiographic Film Processor, Models XP400 and XP1000

FDA 510(k) K024342 · Daito Co., Ltd.

Substantially Equivalent

510(k) numberK024342

Submission

Device name
Radiographic Film Processor, Models XP400 and XP1000
Applicant
Daito Co., Ltd.
Manchester, CT, US
Received
December 27, 2002
Decision date
April 23, 2003
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

Other 510(k)s with product code IXW

510(k)DeviceApplicantDecision
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
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

Questions and answers

When was Radiographic Film Processor, Models XP400 and XP1000 cleared by the FDA?

Radiographic Film Processor, Models XP400 and XP1000 (K024342) received a 510(k) decision of Substantially Equivalent on April 23, 2003, 117 days after the submission was received.

What is the product code of K024342?

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