Optimax, Compact 2, Optimax 2010, Ecomax

Q: What is the product code of K091628?

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

FDA 510(k) K091628 · Protec GmbH & Co. KG

Substantially Equivalent

510(k) numberK091628

Submission

Device name: Optimax, Compact 2, Optimax 2010, Ecomax
Applicant: Protec GmbH & Co. KG
Oberstenfeld, DE
Received: June 4, 2009
Decision date: August 21, 2009
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)	Device	Applicant	Decision
K111167	Xtender Film Processor, Sprint Film Processor Model Xtender Model SprintIXW · Traditional	Velopex International, Inc.	08/18/2011SE
K093503	Intrax Film ProcessorIXW · Traditional	Velopex International, Inc.	01/06/2010SE
K024342	Radiographic Film Processor, Models XP400 and XP1000IXW · Traditional	Daito Co., Ltd.	04/23/2003SE
K023825	Film Processor, Model Life Ray Pro 2500IXW · Abbreviated	S.A.I.E.P. S.R.L.	02/12/2003SE
K023801	Film Processor, Model Life Ray Pro 1000IXW · Abbreviated	S.A.I.E.P. S.R.L.	02/12/2003SE
K023613	AX200 Automatic X-Ray Film Processor, Model 6586.036IXW · Traditional	Alphatek Corp.	01/23/2003SE
K022154	Level 356 X-Ray Film Processor, Models MD & Md-DIXW · Traditional	Fischer Industries, Inc.	09/30/2002SE
K002640	Freedom Automatic Film ProcessorIXW · Abbreviated	J. Morita USA, Inc.	11/08/2000SE
K002404	Micro-Max, Model 319IXW · Traditional	Tek Marketing, Inc.	08/30/2000SE
K001321	All-Pro 2010IXW · Traditional	All-Pro Imaging Corp.	05/16/2000SE

More from All-Pro Imaging Corp.

510(k)	Device	Decision
K992818	Optimax/ Compact 2IXW · Traditional	09/01/1999SE

Questions and answers

When was Optimax, Compact 2, Optimax 2010, Ecomax cleared by the FDA?

Optimax, Compact 2, Optimax 2010, Ecomax (K091628) received a 510(k) decision of Substantially Equivalent on August 21, 2009, 78 days after the submission was received.

What is the product code of K091628?

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