510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K827289Substantially Equivalent

Digital Radiography System

Diagnostic Technology, Inc., Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K827289 is the FDA 510(k) clearance record for DIGITAL RADIOGRAPHY SYSTEM, cleared for Diagnostic Technology, Inc. on . FDA records list 28 510(k) clearances for Diagnostic Technology, Inc., from to . As of , FDA records show no recalls naming K827289.

Clearance record

Decision date
Received
(22 days to decision)
Review panel
Unknown
Applicant
Diagnostic Technology, Inc. Patriots Park, Bedford MA
Third party review
No