Product code IXL— Radiology

FDA has cleared 13 devices under product code IXL between 1980 and 2011, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20111 clearance
• 19971 clearance
• 19951 clearance
• 19942 clearances
• 19921 clearance
• 19902 clearances
• 19882 clearances
• 19841 clearance
• 19811 clearance
• 19801 clearance

• Rms Div.2 clearances
• Applied X-Ray Technologies, Inc.2 clearances
• Philips Medical Systems, Inc.1 clearance
• Philips Medical Systems (Cleveland), Inc.1 clearance
• Machlett Laboratories, Inc.1 clearance
• General Electric Co.1 clearance
• Ge Medical Systems, LLC1 clearance
• GE Medical Systems1 clearance
• Fischer Imaging Corp.1 clearance
• Eastman Kodak Company1 clearance

• K111304 — OPTIMA XR120Ge Medical Systems, LLC·2011-07-19
• K964806 — MD-1835Fischer Imaging Corp.·1997-03-04
• K950317 — ADVANTX 1824 SPOTFILM DEVICEGE Medical Systems·1995-02-08
• K940386 — KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LPEastman Kodak Company·1994-08-17
• K942367 — AXT 1400 SPOTFILM DEVICEApplied X-Ray Technologies, Inc.·1994-06-06
• K924593 — DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4Philips Medical Systems, Inc.·1992-11-24
• K902403 — ELITE R/F SPOT FILM DRIVERms Div.·1990-08-01
• K902146 — SFD-035 SPOT FILM DEVICERms Div.·1990-05-31
• K882492 — A.X.T. SPOTFILM DEVICEApplied X-Ray Technologies, Inc.·1988-07-21
• K881589 — 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400Continental X-Ray Corp.·1988-07-18
• K842184 — SPOT-FILM DEVICE 8835General Electric Co.·1984-07-17
• K802888 — RAYTHEON MEDICAL IMAGINGMachlett Laboratories, Inc.·1981-01-09
• K800554 — MULTI-FORMAT SFD MODEL 1720Philips Medical Systems (Cleveland), Inc.·1980-04-10