Medical Device Manufacturer · US , Burlington , MA

Integra Radionics, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2006

Recent clearances: RADIONICS XKNIFE HDRT SYSTEM, CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM, INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Integra Radionics, Inc. Radiology ✕

6 devices

1-6 of 6

Cleared Apr 22, 2010

LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART

Radiology · 99d

Cleared Apr 08, 2010

Radiology · 51d

Cleared Mar 02, 2009

RADIONICS XKNIFE HDRT SYSTEM

Radiology · 104d

Cleared Oct 16, 2007

INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS

Radiology · 46d

Cleared Dec 21, 2006

INTEGRA RADIONICS IMAGEFUSION 3

Radiology · 57d

Cleared Jul 25, 2006

INTEGRA RADIONICS XKNIFE RT 4

Radiology · 22d