Medical Device Manufacturer · US , Columbia , MD

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

8 submissions · 8 cleared · Since 1987

8

Total

8

Cleared

0

Denied

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

8 devices

1-8 of 8

Cleared Jan 18, 1996

TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE

Radiology · 254d

Cleared Jan 05, 1995

Radiology · 204d

Cleared Apr 27, 1992

Radiology · 55d

Cleared Dec 17, 1991

Radiology · 126d

Cleared Apr 18, 1991

SOPHYCAMERA DSX BODYTRAK

Radiology · 22d

Cleared Oct 27, 1989

SOPHYCAMERA DSX RECTANGULAR

Radiology · 86d

Cleared Oct 26, 1987

SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS

Radiology · 145d

Cleared Aug 12, 1987

DS-7 NUCLEAR MEDICINE GAMMA CAMERA

Radiology · 57d