Medical Device Manufacturer · US , Rockville , MD

Imris, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2006

Recent clearances: SYMBIS Surgical System, HFD100 ROCKER ARM ACCESSORY, IMRI 1.5T AND IMRI 3T S

View 14 510(k) Devices ↓

Total

Cleared

Denied

Imris, Inc. has 14 FDA 510(k) cleared radiology devices. Based in Rockville, US.

Historical record: 14 cleared submissions from 2006 to 2015.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.

Imris, Inc. is one of 18512 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Imris, Inc.

14 devices

1-12 of 14

Cleared Oct 30, 2015

SYMBIS Surgical System

K143420 · HAW

Neurology · 336d

Cleared Sep 04, 2014

HFD100 ROCKER ARM ACCESSORY

K141950 · HBL

Neurology · 48d

Cleared Feb 10, 2014

IMRI 1.5T AND IMRI 3T S

VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T

K123091 · MOS

Radiology · 86d

Cleared Aug 10, 2012

IMRIS ONCOLOGY PACKAGE

K121997 · LNH

Radiology · 32d

Cleared Mar 23, 2012

IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

K113748 · HBL

Radiology · 93d

Cleared Mar 11, 2011

HEAD FIATION DEVICE (HFD 100)

K103493 · HBL

Neurology · 102d

Cleared Feb 02, 2011

1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)

K103506 · MOS

Radiology · 65d

Cleared Oct 05, 2010

IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO

Imris, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Imris, Inc.

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