ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM— 510(k) K023130

Clearance details

Applicant

Mri Devices Corp.

Product code

Code LNH

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2002-09-20

Decision date

2002-10-11

Decision

Substantially Equivalent

Clearance type

Special

Location

Waukesha, WI, US

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• K254250 — MagicScan-1.5, GreenMR Serenity 1.5T2026-08-17
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• K260852 — MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure2026-07-31

• K041286 — DYNACAD V1.02004-07-21
• K041481 — MODEL BBC-127 BIOPSY BREAST COIL2004-07-19
• K040348 — MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL2004-03-09
• K040349 — MODIFICATION TO HRW-127 WRIST ARRAY COIL2004-03-09
• K040288 — QSC-127-INT SHOULDER ARRAY COIL SET2004-03-05

Death

11

Injury

670

Malfunction

1,460

Other

2

Total

2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1440-2020 — Monitor for the Functional Imaging System for Magnetic Resonance Imaging SystemClass II·Terminated·Invivo Corporation·20200206

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023130.