510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K090553Substantially Equivalent

Naviscan Pemflex Solo II High Resolution Pet Scanner

Naviscan, Inc., San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090553 is the FDA 510(k) clearance record for NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER, a class II device, cleared for Naviscan, Inc. on under FDA product code KPS (System, Tomography, Computed, Emission). FDA records list one 510(k) clearance for Naviscan, Inc. As of , FDA records show no recalls naming K090553.

Clearance record

Decision date
Received
(29 days to decision)
Product code
KPS System, Tomography, Computed, Emission
Regulation
21 CFR 892.1200
Device class
Class II
Review panel
Radiology
Applicant
Naviscan, Inc. 6865 Flanders Dr., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KPS

Trailing 12 months
9 clearances under product code KPS in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPS, trailing twelve months
MonthClearances
November 20251
December 20252
January 20261
February 20261
March 20260
April 20261
May 20261
June 20260
July 20261
August 20260
September 20261
October 20260