Medical Device Manufacturer · US , Watertown , MA

General Scanning, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1992

Recent clearances: LD2000 SERIES, DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME), NUCLEAR MEDICINE LASER IMAGER

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - General Scanning, Inc. Radiology ✕

3 devices

1-3 of 3

Cleared Mar 19, 1998

Radiology · 34d

Cleared Dec 04, 1997

DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)

Radiology · 86d

Cleared Nov 30, 1992

NUCLEAR MEDICINE LASER IMAGER

Radiology · 137d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 07, 2026