510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854407Substantially Equivalent

Digirad Reusable Image Media

Digirad Corp., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854407 is the FDA 510(k) clearance record for DIGIRAD REUSABLE IMAGE MEDIA, a class I device, cleared for Digirad Corp. on under FDA product code LQA (Media, Reusable Image). FDA records list 16 510(k) clearances for Digirad Corp., from to . As of , FDA records show no recalls naming K854407.

Clearance record

Decision date
Received
(129 days to decision)
Product code
LQA Media, Reusable Image
Regulation
21 CFR 892.1840
Device class
Class I
Review panel
Radiology
Applicant
Digirad Corp. 1047 Elwell Ct., Palo Alto CA
Third party review
No

Clearances, product code LQA

Trailing 12 months

FDA records hold no clearances under product code LQA in the trailing twelve months.

FDA records show no clearances under product code LQA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LQA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260