Product code IYB— Radiology

FDA has cleared 40 devices under product code IYB between 1978 and 1996, filed by 24 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19961 clearance
• 19951 clearance
• 19943 clearances
• 19932 clearances
• 19923 clearances
• 19914 clearances
• 19901 clearance
• 19893 clearances
• 19886 clearances
• 19872 clearances
• 19863 clearances
• 19854 clearances
• 19842 clearances
• 19813 clearances
• 19782 clearances

• Fischer Imaging Corp.5 clearances
• Shimadzu Medical Systems4 clearances
• Radkor, Inc.3 clearances
• Bennett X-Ray Corp.3 clearances
• Wuestec Medical, Inc.2 clearances
• Tecnomed, Inc.2 clearances
• Medicor USA , Ltd.2 clearances
• General Electric Co.2 clearances
• Acoma Medical Imaging, Inc.2 clearances
• Xri, Inc.1 clearance

• K935123 — SUPERSTAND 300Wuestec Medical, Inc.·1996-03-27
• K946261 — MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000Scott Imaging Intl., Inc.·1995-02-15
• K941004 — CTS SYSTEMAcoma Medical Imaging, Inc.·1994-07-29
• K941017 — F/C/W TUBESTANDAcoma Medical Imaging, Inc.·1994-07-29
• K940442 — MPR-814Xri, Inc.·1994-06-09
• K935004 — MODEL ALPHA TS-2Dpa Consulting, Inc.·1993-12-13
• K933253 — SUPERSTAND 3000Wuestec Medical, Inc.·1993-08-16
• K925716 — BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTCBennett X-Ray Corp.·1992-12-17
• K925170 — SHIMADZU X-RAY TUBE STAND BH-100 SERIESShimadzu Medical Systems·1992-12-07
• K920727 — CEILING TUBE SUPPORT CH-30XShimadzu Medical Systems·1992-04-16
• K914944 — BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTCBennett X-Ray Corp.·1991-12-02
• K914348 — ER-1000 CATHERIZATION C-ARM SYSTEMSShimadzu Medical Systems·1991-11-01
• K911563 — INVENTOR RT/EXPLORER TRAUMA UNITContinental X-Ray Corp.·1991-10-23
• K912696 — TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABLBennett X-Ray Corp.·1991-09-16
• K900234 — PFM-90 CEILING TUBE SUPPORTFischer Imaging Corp.·1990-02-26
• K895188 — SHIMADZU X-RAY TUBE STAND FH-31Shimadzu Medical Systems·1989-09-22
• K893652 — RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60Fischer Imaging Corp.·1989-06-23
• K893653 — RADIOGRAPHIC CEILING TUBE SUPPORT CTS15Fischer Imaging Corp.·1989-06-23
• K883664 — LUM VASCULAR PROCEDURE SYSTEM #B5200AGeneral Electric Co.·1988-11-07
• K883864 — RADKOR SFR-70Radkor, Inc.·1988-10-19
• K881701 — RADKOR SFC-21Radkor, Inc.·1988-09-08
• K882563 — RADKOR, CST-18Radkor, Inc.·1988-07-08
• K880530 — CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEXFischer Imaging Corp.·1988-03-03
• K880528 — OVERHEAD TUBE MOUNT CASCADE IIFischer Imaging Corp.·1988-02-29
• K873283 — MODEL C2-5000 OVERHEAD TUBE SUPPORTTransworld X-Ray Corp.·1987-09-10
• K870856 — COSMOSPausch Corp.·1987-03-30
• K862734 — CEILSTAND, MULTISTAND R & S AND THE BUCKYSTANDD&R X-Ray Products, Inc.·1986-08-01
• K862827 — FCW TUBE STANDGarrels X-Ray Products, Inc.·1986-08-01
• K861995 — MODEL RS-3 RADIOGRAPHIC STANDMedicor USA , Ltd.·1986-06-19
• K852952 — TRAUMA STANDXre Corp.·1985-09-26
• K853682 — MOUNT TUBE RADIOGRAPHICX-Ray Systems·1985-09-19
• K850198 — FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND; RADIOGSummit Industries, Inc.·1985-05-14
• K844337 — X-RAY TUBESTANDS BUCKY STANDS & VETERINARY X-RAYQuality X-Ray Manufacturing, Inc.·1985-02-21
• K843928 — COUNTERBALANCED VERTICAL CASSETTE HOLDERPoersch Metal Mfg. Co.·1984-12-17
• K843335 — FLOOR MOUNTED X-RAY TUBESTANDMedicor USA , Ltd.·1984-11-27
• K811970 — AP X-RAY TUBE ANGULATION DEVICEPhilips Medical Systems (Cleveland), Inc.·1981-08-13
• K811195 — ARGOSTATTecnomed, Inc.·1981-06-09
• K803162 — X-RAY STAND & OPERATING CHAIRDowns Surgical , Ltd.·1981-01-28
• K781571 — L/U ARM-VASCULARGeneral Electric Co.·1978-11-27
• K781065 — PLURIMAT; RADIOGRAPHIC TUBE MOUNTTecnomed, Inc.·1978-07-17