Medical Device Manufacturer · US , Milwaukee , WI

Instrumentarium Imaging, Inc. - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 1989

Recent clearances: DELTA 32 AND DELTA 32 TACT, SIGMA, DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)

24

Total

24

Cleared

0

Denied

FDA 510(k) Regulatory Record - Instrumentarium Imaging, Inc. Radiology ✕

24 devices

1-12 of 24

Cleared Nov 29, 2000

DELTA 32 AND DELTA 32 TACT

Radiology · 110d

Cleared Aug 02, 2000

Radiology · 37d

Cleared Jun 01, 2000

DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)

Radiology · 66d

Cleared May 12, 2000

Radiology · 31d

Cleared Nov 21, 1997

ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100

Radiology · 58d

Cleared Mar 21, 1996

Radiology · 115d

Cleared May 19, 1993

INSTRUMENTARIUM MEGA4 HT

Radiology · 175d

Cleared May 17, 1993

INSTRUMENTARIUM MEGA4 HT

Radiology · 234d

Cleared May 03, 1993

INSTRUMENTARIUM MEGA4 HT

Radiology · 287d

Cleared May 03, 1993

INSTRUMENTARIUM MEGA4 HT

Radiology · 243d

Cleared Oct 06, 1992

INSTRUMENTARIUM MEGA4 HT

Radiology · 90d

Cleared Sep 22, 1992

INSTRUMENTARIUM MEGA4 HT

Radiology · 91d