Product code IWA— Radiology

FDA has cleared 8 devices under product code IWA between 1977 and 1992, filed by 6 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.

• 19921 clearance
• 19891 clearance
• 19881 clearance
• 19854 clearances
• 19771 clearance

• Syncor Intl. Corp.2 clearances
• Rads S.L., Inc.2 clearances
• Radiation Safety & Nuclear Products, Inc.1 clearance
• Omnitron Intl., Inc.1 clearance
• Cis Radiopharmaceuticals, Inc.1 clearance
• Amersham Corp.1 clearance

• K915253 — IR-192 IMPLANT, MODIFICATIONOmnitron Intl., Inc.·1992-02-27
• K894409 — CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELDAmersham Corp.·1989-09-29
• K874895 — IR-192 IMPLANTRads S.L., Inc.·1988-02-25
• K850382 — IRIDIUM SEEDSRadiation Safety & Nuclear Products, Inc.·1985-08-15
• K844248 — IR-192 IMPLANTRads S.L., Inc.·1985-04-10
• K850163 — IRIDIUM 192 WIRESSyncor Intl. Corp.·1985-03-26
• K850726 — WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELDSyncor Intl. Corp.·1985-03-26
• K771878 — IRIDIUM 192 WIRES & PINSCis Radiopharmaceuticals, Inc.·1977-10-27