510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K964626Substantially Equivalent

Edge/vista System Enhancement Package

Philips North America LLC, Highland Heights OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964626 is the FDA 510(k) clearance record for EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE, a class II device, cleared for Philips Medical Systems (Cleveland), Inc. on under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show 4 recalls naming K964626.

Clearance record

Decision date
Received
(83 days to decision)
Product code
LNH System, Nuclear Magnetic Resonance Imaging
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Philips Medical Systems (Cleveland), Inc. 5500 Avion Park Dr., Highland Heights OH
510(k) summary
Summary
Third party review
No

Clearances, product code LNH

Trailing 12 months
26 clearances under product code LNH in the twelve months to October 2026, March 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code LNH, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20264
March 20266
April 20261
May 20261
June 20260
July 20262
August 20263
September 20263
October 20261