1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL— 510(k) K093284

Clearance details

Applicant

Invivo Corporation

Product code

Code MOS

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2009-10-20

Decision date

2010-02-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Florida, FL, US

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• K262294 — dS FootAnkle 16Ch 1.5T +5 more2026-07-24
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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

• 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-0548-2025 — ST SENSE Breast Dx CoilClass II·Ongoing·Philips North America Llc·20241104

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093284.