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510(k) K828562

DIGIRAD CFR 2000 RADIOGRAPHIC FILM CASSETTE by Digirad Corp.

K828562 is an FDA 510(k) premarket notification submitted by Digirad Corp. for the device "DIGIRAD CFR 2000 RADIOGRAPHIC FILM CASSETTE". The FDA issued a decision of Substantially Equivalent on April 28, 1983. Digirad Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1983
Date Received
November 16, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Digirad Corp.

  • K123408 — ERGO IMAGING SYSTEM (January 15, 2013)
  • K100838 — ERGO IMAGING SYSTEM (April 23, 2010)
  • K083649 — CARDIUS 3 X-ACT (March 9, 2009)
  • K082904 — STASYS MOTION CORRECTION SOFTWARE (December 17, 2008)
  • K082368 — CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMA (September 12, 2008)
  • K070542 — CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS (March 23, 2007)
  • K052430 — CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM (October 4, 2005)
  • K051549 — CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM (July 13, 2005)
  • K030085 — CARDIUS-1 AND CARDIS-2 (February 5, 2003)
  • K023110 — CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 (November 22, 2002)

FDA data resources