510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161767Substantially Equivalent

Philips IntelliVue GuardianSoftware

Philips Medizin Systeme Boeblingen GmbH, Boeblingen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161767 is the FDA 510(k) clearance record for Philips IntelliVue GuardianSoftware, a class II device, cleared for Philips Medizin Systeme Boeblingen GmbH on under FDA product code DXJ (Display, Cathode-Ray Tube, Medical). FDA records list 48 510(k) clearances for Philips Medizin Systeme Boeblingen GmbH, from to . As of , FDA records show no recalls naming K161767.

Clearance record

Decision date
Received
(214 days to decision)
Product code
DXJ Display, Cathode-Ray Tube, Medical
Regulation
21 CFR 870.2450
Device class
Class II
Review panel
Cardiovascular
Applicant
Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard St. 2, Boeblingen, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXJ

Trailing 12 months

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

FDA records show no clearances under product code DXJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXJ, 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