Medical Device Manufacturer · US , South San Fransisco , CA

Imatron, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1983

11

Total

11

Cleared

0

Denied

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

11 devices

1-11 of 11

Cleared Dec 11, 2000

EBT ULTRAFAST CT SCANNER SYSTEM

Radiology · 207d

Cleared Mar 17, 2000

EBT ULTRAFAST CT SCANNER SYSTEM

Radiology · 42d

Cleared Nov 09, 1999

EBT ULTRAFAST CT SCANNER SYSTEM

Radiology · 85d

Cleared Nov 04, 1997

IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS

Radiology · 90d

Cleared Oct 15, 1997

ULTRAFAST CT SCANNER

Radiology · 71d

Cleared Nov 29, 1991

C-150 ULTRAFAST CT SCANNER

Radiology · 126d

Cleared Jan 19, 1988

UNIVERSAL EXAMINATION TABLE

Radiology · 46d

Cleared Sep 23, 1987

IMATRON C-100 ULTRAFAST CT SCANNER

Radiology · 79d

Cleared Nov 10, 1986

C-IOO MOBILE CINE CT UNIT

Radiology · 25d

Cleared Feb 21, 1984

COMPUTED TOMOGRAPHY CALIBRATION PHANT

Radiology · 42d

Cleared Jan 14, 1983

COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100

Radiology · 45d