Medical Device Manufacturer · US , Wilmington , MA

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

7 submissions · 7 cleared · Since 2001

Recent clearances: MODIFICATION TO AURORA MRI SYSTEM, MODIFICATION TO: AURORA, MODIFICATION TO: AURORA

View 7 510(k) Devices ↓

7

Total

7

Cleared

0

Denied

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

7 devices

1-7 of 7

Cleared Sep 16, 2008

MODIFICATION TO AURORA MRI SYSTEM

Radiology · 288d

Cleared Nov 08, 2005

MODIFICATION TO: AURORA

Radiology · 41d

Cleared Sep 24, 2003

MODIFICATION TO: AURORA

Radiology · 26d

Cleared Jul 30, 2003

Radiology · 23d

Cleared Jan 29, 2003

AURORA MR-GUIDED INTERVENTIONAL SYSTEM

Radiology · 89d

Cleared Sep 19, 2001

AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Radiology · 70d

Cleared Feb 21, 2001

Radiology · 86d