Product code IZP— Radiology

FDA has cleared 10 devices under product code IZP between 1984 and 1993, filed by 7 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.

• 19931 clearance
• 19911 clearance
• 19902 clearances
• 19881 clearance
• 19851 clearance
• 19844 clearances

• Elema-Schonander, Inc.4 clearances
• Sybron Corp.1 clearance
• Philips Medical Systems North America, Inc.1 clearance
• Medrad, Inc.1 clearance
• Mallinckrodt Group, Inc.1 clearance
• Changer Service & Engineering, Inc.1 clearance
• Cgr Medical Corp.1 clearance

• K934944 — MPQ-42Elema-Schonander, Inc.·1993-12-15
• K911888 — PHILIPS ANGIOPROPhilips Medical Systems North America, Inc.·1991-10-15
• K904144 — PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEMMallinckrodt Group, Inc.·1990-12-13
• K904103 — SEP 90Elema-Schonander, Inc.·1990-11-20
• K874451 — OMNIPLANE 200 FILM CHANGER SYSTEMMedrad, Inc.·1988-02-11
• K854251 — THE CSE FILM CHANGER SYSTEMChanger Service & Engineering, Inc.·1985-10-28
• K842903 — SEP PROGRAMMER FOR PUCK U & UD FILMCHANGElema-Schonander, Inc.·1984-08-21
• K841649 — MAXIMAX - 4Cgr Medical Corp.·1984-06-05
• K841732 — LIEBEL-FLARSHEIM AFC 1000 X-RAY FILMSybron Corp.·1984-06-05
• K840389 — SEP PROGRAMMER SEP-M/SINGLE-PLANE &Elema-Schonander, Inc.·1984-02-21