Product code LHO— Radiology

FDA has cleared 8 devices under product code LHO between 1984 and 2004, filed by 4 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.

• 20041 clearance
• 19871 clearance
• 19863 clearances
• 19852 clearances
• 19841 clearance

• Victoreen, Inc.3 clearances
• Varian Assoc., Inc.2 clearances
• Radiation Measurements, Inc.2 clearances
• Standard Imaging, Inc.1 clearance

• K042733 — STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEMStandard Imaging, Inc.·2004-11-15
• K873956 — ULTIMETERRadiation Measurements, Inc.·1987-10-30
• K853754 — MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901Victoreen, Inc.·1986-05-07
• K860260 — MULTI PURPOSE MODEL 76-903Victoreen, Inc.·1986-05-07
• K860100 — MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902Victoreen, Inc.·1986-04-22
• K844620 — BDS-3 BEAM DATA SCANNERVarian Assoc., Inc.·1985-07-01
• K845007 — RFA-7 RADIATION FIELD ANALYZERVarian Assoc., Inc.·1985-07-01
• K834483 — DIGI-XRadiation Measurements, Inc.·1984-03-05