Medical Device Manufacturer · CA , Nepean, Ontario

Is2 Research, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1998

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Is2 Research, Inc. Radiology ✕

7 devices

1-7 of 7

Cleared Feb 02, 2004

MOBILE COMPACT DIGITAL CARDIAC CAMERA

Radiology · 20d

Cleared Jan 20, 2004

MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)

Radiology · 29d

Cleared Dec 17, 2003

MODIFICATION TO: NUCAMMA RX

Radiology · 100d

Cleared Jan 28, 2002

BCC GAMMA CAMERA

Radiology · 83d

Cleared Feb 21, 2001

Radiology · 68d

Cleared Sep 02, 1998

Radiology · 84d

Cleared Sep 02, 1998

Radiology · 84d