MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS— 510(k) K053017

Clearance details

Applicant

Invivo Corporation

Product code

Code MOS

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2005-10-26

Decision date

2005-11-16

Decision

Substantially Equivalent

Clearance type

Special

Location

Pewaukee, WI, US

• K262330 — dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T2026-07-30
• K262294 — dS FootAnkle 16Ch 1.5T +5 more2026-07-24
• K260947 — 0.55T 12Ch Breast Coil2026-04-23
• K252587 — HD 8Ch Wrist Array2026-04-14
• K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only +2 more2026-04-01

• K213766 — dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T2021-12-23
• K212227 — Philips MR Patient Care Portal2021-09-30
• K212175 — DynaCAD2021-08-02
• K193403 — UroNav System2019-12-27
• K192200 — DynaCAD2019-10-09

• Z-0126-2021 — MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.Class III·Terminated·Invivo Corporation·20200914

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053017.