FDA.reportPublic FDA data

510(k) K022154

Device
LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D
Applicant
Fischer Industries, Inc.
510(k) number
K022154
Product code
IXW
Decision
Substantially Equivalent (SESE)
Decision date
2002-09-30
Date received
2002-07-02
Regulation
892.1900
Classification name
Processor, Radiographic-Film, Automatic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
PHIL O'KEEFE
Address
2630 Kaneville Ct. Geneva IL US 60134 60134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IXW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K111167XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINTVelopex International, Inc.2011-08-18
K093503INTRAX FILM PROCESSORVelopex International, Inc.2010-01-06
K091628OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAXProtec GmbH & Co. KG2009-08-21
K024342RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000Daito Co., Ltd.2003-04-23
K023801FILM PROCESSOR, MODEL LIFE RAY PRO 1000S.A.I.E.P. S.R.L.2003-02-12
K023825FILM PROCESSOR, MODEL LIFE RAY PRO 2500S.A.I.E.P. S.R.L.2003-02-12
K023613AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036Alphatek Corp.2003-01-23
K002640FREEDOM AUTOMATIC FILM PROCESSORJ. Morita USA, Inc.2000-11-08
K002404MICRO-MAX, MODEL 319Tek Marketing, Inc.2000-08-30
K001321ALL-PRO 2010All-Pro Imaging Corp.2000-05-16
K992818OPTIMAX/ COMPACT 2Protec GmbH & Co. KG1999-09-01
K990969KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSORKonica Medical Corp.1999-06-18
K991435AII-PRO 100 PLUS AND ALL-PRO 200All-Pro Imaging Corp.1999-05-20
K981280CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMSBayer Corp., Agfa Div.1998-04-30
K973125MAMMOLOADER BY C.M.A. SRLC.M.A.1997-10-08