1.5T 24E Posterior Array— 510(k) K223203

Name: FDA 510(k) clearance K223203
Creator: U.S. Food and Drug Administration
Published: 2023-03-02

Substantially Equivalent

Shenzhen RF Tech Co., Ltd.

FDA 510(k) clearance K223203 for 1.5T 24E Posterior Array, Substantially Equivalent on 2023-03-02. Applicant: Shenzhen RF Tech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen RF Tech Co., Ltd.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2022-10-14
Decision date: 2023-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNH

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K254250 — MagicScan-1.5, GreenMR Serenity 1.5T2026-08-17
K253808 — AIR Recon DL2026-08-13
K260852 — MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure2026-07-31

More clearances from Shenzhen RF Tech Co., Ltd.

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K252587 — HD 8Ch Wrist Array2026-04-14
K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only +2 more2026-04-01
K252179 — GEM Flex Coil 16-L Array, 1.5T Receive Only +2 more2026-02-10
K231085 — 1.5T HD T/R Knee Array (10-F34127)2023-08-18
K223225 — 8ch T/R Knee Coil2023-02-14

Adverse events under product code LNH

product code LNH

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.