BIOPSY BREAST COIL, MODEL BBC— 510(k) K032576

Clearance details

Applicant

Mri Devices Corp.

Product code

Code MOS

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2003-08-20

Decision date

2003-10-23

Decision

Substantially Equivalent

Clearance type

Special

Location

Waukesha, 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

• 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

• Z-0536-2025 — Achieva TX Interventional Coil 3.0TClass II·Ongoing·Philips North America Llc·20241104
• Z-0539-2025 — dS Breast 7ch 1.5TClass II·Ongoing·Philips North America Llc·20241104
• Z-0540-2025 — dS Breast 7ch 3.0TClass II·Ongoing·Philips North America Llc·20241104
• Z-0542-2025 — Mammotrak Interventional Coil 1.5TClass 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 K032576.