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510(k) K923141

Device
Philips Pre-filter Option
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
510(k) number
K923141
Product code
ITY
Decision
Substantially Equivalent (SESE)
Decision date
1993-01-21
Date received
1992-06-29
Regulation
892.1760
Classification name
Assembly, Tube Housing, X-Ray, Diagnostic
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM G MCMAHON
Address
Veenpluis 4-6 P.O. Box 10000 5680 Da Best NL

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ITY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K000052X-RAY MONOBLOCK, MONOBLOCK XRS-60-330Dynarad Corp.2000-02-10
K933162MRX-750Mrx Corp.1993-10-07
K923094MOLYBDENUMSoutheastern Medical Diagnostics, Inc.1993-03-04
K921129MRX-700Mrx-Ray Tube Corp.1992-10-05
K921130MRX-865Mrx-Ray Tube Corp.1992-09-10
K921316MG-1001 TUBE HOUSING ASSEMBLYMagma Corp.1992-06-22
K920731X-RAY TUBE ASSEMBLY CIRCLEX1.2UGShimadzu Medical Systems1992-05-29
K920724HIGH SPEED ROTATION STARTER SA-50Shimadzu Medical Systems1992-04-27
K920723HIGH SPEED ROTATION STARTER SA-40Shimadzu Medical Systems1992-04-27
K920387CIRCLEXO.3T X-RAY TUBE ASSEMBLYShimadzu Medical Systems1992-04-14
K913987OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUIDCodman & Shurtleff, Inc.1992-04-13
K913301MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEMComet North America, Inc.1991-08-28
K912338TUBE HOUSING ASSEMBLIESComet Ltd. C/O Radiology Resources, Inc.1991-08-07
K911695VARIOUS X-RAY TUBESComet Ltd. C/O Radiology Resources, Inc.1991-06-19
K910308X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110Inmark Corp.1991-03-27