DeviceClearance

Azurion series R1.2— 510(k) K172822

Substantially Equivalent

Philips Medical Systems Nederland B.V.

FDA 510(k) clearance K172822 for Azurion series R1.2, Substantially Equivalent on 2017-11-22. Applicant: Philips Medical Systems Nederland B.V.. Device class: 2.

Clearance details

Applicant
Philips Medical Systems Nederland B.V.
Product code
Code OWB
Device class
Class 2
Regulation
21 CFR 892.1650
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Best Noord-Brabant, NL
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OWB

product code OWB
Death
49
Injury
340
Malfunction
36,973
Total
37,362

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K172822

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172822.

Data sourced from openFDA. This site is unofficial and independent of the FDA.