ITY — Assembly, Tube Housing, X-Ray, Diagnostic Class I

FDA Device Classification

Classification Details

Product Code
ITY
Device Class
Class I
Regulation Number
892.1760
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K000052dynaradX-RAY MONOBLOCK, MONOBLOCK XRS-60-330February 10, 2000
K933162mrxMRX-750October 7, 1993
K923094southeastern medical diagnosticsMOLYBDENUMMarch 4, 1993
K923141philips medical systemsPHILIPS PRE-FILTER OPTIONJanuary 21, 1993
K921129mrx-ray tubeMRX-700October 5, 1992
K921130mrx-ray tubeMRX-865September 10, 1992
K921316magmaMG-1001 TUBE HOUSING ASSEMBLYJune 22, 1992
K920731shimadzu medical systemsX-RAY TUBE ASSEMBLY CIRCLEX1.2UGMay 29, 1992
K920723shimadzu medical systemsHIGH SPEED ROTATION STARTER SA-40April 27, 1992
K920724shimadzu medical systemsHIGH SPEED ROTATION STARTER SA-50April 27, 1992
K920387shimadzu medical systemsCIRCLEXO.3T X-RAY TUBE ASSEMBLYApril 14, 1992
K913987codman and shurtleffOR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUIDApril 13, 1992
K913301comet north americaMCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEMAugust 28, 1991
K912338comet ltd. c/o radiology resourcesTUBE HOUSING ASSEMBLIESAugust 7, 1991
K911695comet ltd. c/o radiology resourcesVARIOUS X-RAY TUBESJune 19, 1991
K910308inmarkX-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110March 27, 1991
K910276inmarkX-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51March 6, 1991
K910842comet ltd. c/o radiology resourcesDI2000/HS-45-150 X-RAY TUBE INSERTMarch 6, 1991
K904182advantechR-800-SFNovember 13, 1990
K900367hofmannHOFMANN-NAGEL (HOFNA) X-RAY TUBESFebruary 26, 1990