Assembly, Tube Housing, X-ray, Diagnostic

Product Code: ITY

Radiology Medical Diagnostic X-Ray Equipment

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]

Code of Federal Regulations: 892.1760


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as ITY

5277Assembly, Tube Housing, X-ray, DiagnosticDiagnostic X-ray Tube Housing Assembly.

Total Product Life Cycle (TPLC) Devices

5277Assembly, Tube Housing, X-ray, DiagnosticDiagnostic X-ray Tube Housing Assembly.

FDA Consensus Standards

Assembly, Tube Housing, X-Ray, Diagnostic [37593]21 CFR §892.1760 🔎
Assembly, Tube Housing, X-Ray, Diagnostic [37630]21 CFR §892.1760 🔎
Assembly, Tube Housing, X-Ray, Diagnostic [37992]21 CFR §892.1760 🔎
Assembly, Tube Housing, X-Ray, Diagnostic [15092]21 CFR §892.1760 🔎

Pre-market Notifications for ITY

K000052X-RAY MONOBLOCK, MONOBLOCK XRS-60-330DYNARAD CORP.
K933162MRX-750MRX CORP.
K923094MOLYBDENUMSOUTHEASTERN MEDICAL DIAGNOSTICS, INC.
K921316MG-1001 TUBE HOUSING ASSEMBLYMAGMA CORP.
K921129MRX-700MRX-RAY TUBE CORP.
K921130MRX-865MRX-RAY TUBE CORP.
K920731X-RAY TUBE ASSEMBLY CIRCLEX1.2UGSHIMADZU MEDICAL SYSTEMS
K920723HIGH SPEED ROTATION STARTER SA-40SHIMADZU MEDICAL SYSTEMS
K920724HIGH SPEED ROTATION STARTER SA-50SHIMADZU MEDICAL SYSTEMS
K920387CIRCLEXO.3T X-RAY TUBE ASSEMBLYSHIMADZU MEDICAL SYSTEMS
K913987OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUIDCodman & Shurtleff, Inc.
K913301MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEMCOMET NORTH AMERICA, INC.
K912338TUBE HOUSING ASSEMBLIESCOMET LTD. C/O RADIOLOGY RESOURCES, INC.
K911695VARIOUS X-RAY TUBESCOMET LTD. C/O RADIOLOGY RESOURCES, INC.
K910842DI2000/HS-45-150 X-RAY TUBE INSERTCOMET LTD. C/O RADIOLOGY RESOURCES, INC.

Global Unique Device Identification Database

00884838093034Assembly, tube housing, x-ray, diagnostic
00884838093010Assembly, tube housing, x-ray, diagnostic
00884838093003Assembly, tube housing, x-ray, diagnostic
00884838092990Assembly, tube housing, x-ray, diagnostic
00884838092983Assembly, tube housing, x-ray, diagnostic
00884838092976Assembly, tube housing, x-ray, diagnostic
00884838092969Assembly, tube housing, x-ray, diagnostic
00884838092952Assembly, tube housing, x-ray, diagnostic
00884838092945Assembly, tube housing, x-ray, diagnostic
00884838092921Assembly, tube housing, x-ray, diagnostic
00884838092914Assembly, tube housing, x-ray, diagnostic
00884838092907Assembly, tube housing, x-ray, diagnostic
00884838092891Assembly, tube housing, x-ray, diagnostic
00884838092884Assembly, tube housing, x-ray, diagnostic
00884838092877Assembly, tube housing, x-ray, diagnostic

Maude Adverse Events

VARIANVARIAN MEDICAL SYSTEMS2012-04-27
ASSEMBLY, 9300XSP L/S W/APSW TINTEGRA, BURLINGTON2011-09-30
VARIANVARIAN MEDICAL SYSTEMS2011-02-11
104181 EASYDIAGNOST 9" II DSI-UPHILIPS MEDICAL SYSTEMS NORTH AMERICA2009-01-29
FINAL ASSY, DR1000LIEBEL - FLARSHEIM CO.2009-01-07
SUPPORT ARMMAQUET CRITICAL CARE AB2006-07-14
D3112T TUBEGE MEDICAL SYSTEMS SCS2005-11-22
ADNEXAADNEXA CORP2005-10-20
B & K ULTRASOUND MACHINEB-K MEDICAL2004-07-14
TRAUMEXFISCHER IMAGING CORP.2004-05-05
HTG CASINGG.E. MEDICAL SYSTEMS2004-03-25
UROPRO UROLOGY IMAGING SYSTEMARCOMA AB2003-07-31
*LEAD FILTER*2003-07-28
SIEMENSSIEMENS2003-01-21
SAPPHIRE 150TH / RAD 21VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS2001-12-05
ATLANTIS SR (IVWS)BOSTON SCIENTIFIC SCIMED2001-10-02
SRO 33/100 X-RAY TUBE ASSEMBLYPHILIPS MEDEZIN SYSTEME2001-06-29
2001-06-29
GENERAL ELECTRICGENERAL ELECTRIC2001-06-15
TRAUMEXFISCHER IMAGING CORP.2001-06-07
*X-RAY TUBEGE MEDICAL SYSTEMS2001-04-19
NIX-RAY TUBEPHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.2000-04-07
ELITE 1500EFISCHER IMAGING CORP.2000-02-16
**FISCHER IMAGING CORP.1999-12-22
VARIAN A292/B150VARIAN INTERAY1998-10-15
MACHLETT-DYNAMAX 50VARIAN X-RAY TUBE PRODUCTS1998-09-29
LIEBEL FLARSHEIMEUREKA X-RAY TUBE CO.1998-08-07
APOLLO X-RAY TUBE CEILINGPICKER INT'L., INC.1998-02-17
FISCHER IMAGING CORPFISCHER IMAGING CORP1997-12-31
SAPPHIRE / RAD-60 S/N AT47337VARIAN X-RAY TUBE PRODUCTS1997-12-19
RAD 60 X-RAY TUBEVARIAN ASSOCIATES INC.1997-12-15
GENERAL ELECTRICGENERAL ELECTRIC MEDICAL SYSTEMS1997-10-28
BUCKY DIAGNOST CS 2PHILIPS SYSTEME MEDEZIN1997-07-25
TOSHIBATOSHIBA CORPORATION1997-06-13
TRAUMEXFISCHER IMAGING CORP.1997-06-09
CARDIAC CXFISCHER IMAGING CORP.1997-05-12
***1997-05-12
SUSPENSION TYPE 6GENERAL ELECTRIC CO.1997-05-01
SRO 33/100 X-RAY TUBE ASSEMBLYPHILIPS SYSTEME MEDEZIN1997-03-26
DOUBLE MONITOR SUSPENSIONGE MEDICAL SYS1997-03-04
STORZ IMAGING SYSTEM C-ARMFISHER IMAGING CORP.1997-02-26
SOLARIX TUBE/BUCKY STANDGE MEDICAL SYSTEMS EUROPE1997-01-30
BENNETT S82RM6BENNETT, SUBSIDIARY OF TREX MED.1997-01-24
SAPPHIRE 150THVARIAN X-RAY TUBE PRODUCTS1997-01-09
FOUR MONITOR SUSPENSIONPHILIPS MEDICAL SYSTEMS NORTH AMERICA1996-11-19
EDEC 80 X-RAY MACHINE AND CGRUNK1996-07-13
EDEC 80 X-RAY MACHINEUNK1996-07-13
G.E. PRESTILIX 1600SG.E. MEDICAL SYSTEMS1995-07-06
TUBE HOUSING ASSEMBLYPICKER INTL.1995-05-23
*HIGH PRESSURE TUBINGMERIT MEDICAL SYSTEMS, INC.1995-02-15

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