Product code IWS— Radiology

FDA has cleared 6 devices under product code IWS between 1992 and 1995, filed by 5 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.

• 19951 clearance
• 19943 clearances
• 19931 clearance
• 19921 clearance

• Medtec, Inc.2 clearances
• Victoreen, Inc.1 clearance
• Med-Genesis, Inc.1 clearance
• Burkhart Roentgen Intl., Inc.1 clearance
• Best Industries1 clearance

• K945515 — COATED TUNGSTEN EYESHIELDMedtec, Inc.·1995-06-19
• K940119 — ROYAL MARSDEN GOLD GRAIN GUNBest Industries·1994-12-30
• K943011 — TUNGSTEN EYESHIELDMedtec, Inc.·1994-12-23
• K934459 — MED-GENESIS PATIENT LASER EYE SHIELDMed-Genesis, Inc.·1994-02-22
• K934362 — NUCLEAR ASSOCIATES GLASSERSVictoreen, Inc.·1993-11-12
• K920540 — RADIOLOGICAL PROTECTIVE EYE SHIELDBurkhart Roentgen Intl., Inc.·1992-05-28