Medical Device Manufacturer · CA , Lachine Quebec

Park Medical Systems, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1997

Recent clearances: ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA), ISOCAM II (DUAL HEAD GAMMA CAMERA)

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Park Medical Systems, Inc. Radiology ✕

2 devices

1-2 of 2

Cleared Apr 11, 1997

ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)

Radiology · 87d

Cleared Feb 28, 1997

ISOCAM II (DUAL HEAD GAMMA CAMERA)

Radiology · 88d