Medical Device Manufacturer · US , Ridgefield Park , NJ

Bayer Corp., Agfa Div. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1997

Recent clearances: CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS, ADC COMPACT (AGFA DIAGNOSTIC CENTER), LR 5200 LASER FILM RECORDER

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bayer Corp., Agfa Div. Radiology ✕

3 devices

1-3 of 3

Cleared Apr 30, 1998

CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY...

Radiology · 22d

Cleared Mar 09, 1998

ADC COMPACT (AGFA DIAGNOSTIC CENTER)

Radiology · 90d

Cleared Jan 27, 1997

LR 5200 LASER FILM RECORDER

Radiology · 83d