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510(k) K854407

DIGIRAD REUSABLE IMAGE MEDIA by Digirad Corp. — Product Code LQA

K854407 is an FDA 510(k) premarket notification submitted by Digirad Corp. for the device "DIGIRAD REUSABLE IMAGE MEDIA". The FDA issued a decision of Substantially Equivalent on March 10, 1986. The device falls under product code LQA (Media, Reusable Image), a Class I device regulated under 21 CFR 892.1840. Digirad Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1986
Date Received
November 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reusable Image
Device Class
Class I
Regulation Number
892.1840
Review Panel
RA
Submission Type

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