510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K828606Substantially Equivalent

Model Pdx-4800 Projection Digital X-Ray System

Philips North America LLC, Denmark, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K828606 is the FDA 510(k) clearance record for MODEL PDX-4800 PROJECTION DIGITAL X-RAY SYSTEM, cleared for Adac Laboratories on . FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K828606.

Clearance record

Decision date
Received
(35 days to decision)
Review panel
Unknown
Applicant
Adac Laboratories Jellingvej 5, Denmark, DK
Third party review
No