Medical Device Manufacturer · US , Indianpolis , IN

Pie Medical - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2000

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pie Medical Radiology ✕

12 devices

1-12 of 12

Cleared Sep 06, 2006

ART LAB SOFTWARE

Radiology · 57d

Cleared Dec 16, 2005

MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM

Radiology · 32d

Cleared Jan 25, 2005

MYLAB 15 / MYLAB 20, MODEL 2700

Radiology · 28d

Cleared Jan 05, 2005

Radiology · 29d

Cleared Jul 23, 2004

PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS

Radiology · 32d

Cleared Dec 15, 2003

TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L

Radiology · 28d

Cleared Jan 24, 2003

PICUS ULTRASOUND IMAGING SYSTEMS

Radiology · 95d

Cleared Apr 19, 2002

50S TRINGA ULTRASOUND IMAGING SYSTEM

Radiology · 98d

Cleared Mar 01, 2001

240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS

Radiology · 87d

Cleared Jan 05, 2001

Radiology · 77d

Cleared Nov 09, 2000

100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS

Radiology · 99d

Cleared Oct 26, 2000

300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC

Radiology · 41d