LBS-63-16 BREAST ARRAY COIL— 510(k) K072873
Substantially EquivalentInvivo
FDA 510(k) clearance K072873 for LBS-63-16 BREAST ARRAY COIL, Substantially Equivalent on 2007-11-16. Applicant: Invivo. Device class: 2.
Clearance details
- Applicant
- Invivo
- Product code
- Code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Florida, FL, US
Recent devices under product code MOS
view all- 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 3.0T
- K262294 — dS FootAnkle 16Ch 1.5T +5 more
- K260947 — 0.55T 12Ch Breast Coil
- K252587 — HD 8Ch Wrist Array
- K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only +2 more
More clearances from Invivo
view all- K091902 — 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484
- K082987 — HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL
- K082916 — HRB-127-32 HIGH RESOLUTION BRAIN COIL
- K072874 — LBS-127-16 BREAST ARRAY COIL
- K061952 — CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16
Recalls naming K072873
K-number listed on FDA's recall record- Z-0537-2025 — dS Breast 16ch 1.5T
- Z-0538-2025 — dS Breast 16ch 3.0T
- Z-0541-2025 — Mammotrak Diagnostic Coil 1.5T
- Z-0543-2025 — Mammotrak Diagnostic Coil 3.0T
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072873.
Data sourced from openFDA. This site is unofficial and independent of the FDA.