510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K001026Substantially Equivalent

3D-Mspect

The Reagents of the University of Michigan, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001026 is the FDA 510(k) clearance record for 3D-MSPECT, a class II device, cleared for The Reagents of the University of Michigan on under FDA product code KPS (System, Tomography, Computed, Emission). FDA records list one 510(k) clearance for The Reagents of the University of Michigan. As of , FDA records show no recalls naming K001026.

Clearance record

Decision date
Received
(82 days to decision)
Product code
KPS System, Tomography, Computed, Emission
Regulation
21 CFR 892.1200
Device class
Class II
Review panel
Radiology
Applicant
The Reagents of the University of Michigan 49 Plain St., North Attleboro MA
510(k) summary
Summary
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