Medical Device Manufacturer · US , Tewksbury , MA

Instrumentarium Corp. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 1983

20

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Instrumentarium Corp. Radiology ✕

12 devices

1-12 of 12

Cleared Oct 09, 2002

MODIFICATION TO FOCUS

Radiology · 63d

Cleared Jul 13, 2000

Radiology · 36d

Cleared Jun 22, 2000

ORTHOCEPH OC100 D

Radiology · 45d

Cleared Sep 28, 1999

ORTHOPANTOMOGRAPH OP100D

Radiology · 74d

Cleared Jul 17, 1998

MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST,...

Radiology · 70d

Cleared Jan 31, 1995

Radiology · 504d

Cleared Apr 27, 1993

ORTHOCEPH OC100

Radiology · 92d

Cleared Nov 05, 1991

ORTHOPANTOMOGRAPH 100

Radiology · 127d

Cleared Nov 10, 1988

INSTRUMENTARIUM ULF MR IMAGING SYSTEM

Radiology · 77d

Cleared Oct 19, 1988

INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H

Radiology · 51d

Cleared Sep 16, 1988

INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110

Radiology · 18d

Cleared Sep 14, 1988

INSTRUMENTARIUM ULF MR IMAGING SYSTEM

Radiology · 20d