LBS-63-16 BREAST ARRAY COIL
FDA 510(k) clearance K072873 · decided 2007-11-16
Clearance details
- K-number
- K072873
- Device name
- LBS-63-16 BREAST ARRAY COIL
- Applicant
- Invivo
- Decision
- Substantially Equivalent
- Date received
- 2007-10-09
- Decision date
- 2007-11-16
- Days to decision
- 38 days
- Clearance type
- Special
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Florida, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| dS Breast 16ch 1.5T recall (Z-0537-2025) | Philips North America Llc | 2024-11-25 |
| dS Breast 16ch 3.0T recall (Z-0538-2025) | Philips North America Llc | 2024-11-25 |
| Mammotrak Diagnostic Coil 1.5T recall (Z-0541-2025) | Philips North America Llc | 2024-11-25 |
| Mammotrak Diagnostic Coil 3.0T recall (Z-0543-2025) | Philips North America Llc | 2024-11-25 |