FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
0.55T 12Ch Breast Coil
K Number: K260947
·
Decision Apr 23, 2026
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
17
Review Days
31
Basic Information
- Device Name
- 0.55T 12Ch Breast Coil
- K Number
- K260947
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neocoil, LLC
- Date Received
- March 23, 2026
- Decision Date
- April 23, 2026
- Product Code
- MOS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | FDA class 2 | Radiology |
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Other Clearances by Neocoil, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K222407 | 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil | Oct 14, 2022 | Substantially Equivalent |
| K213687 | 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch | Mar 11, 2022 | Substantially Equivalent |
| K201101 | 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil | Jun 2, 2020 | Substantially Equivalent |
| K182958 | 1.5T 16ch Breast Coil | Nov 16, 2018 | Substantially Equivalent |
| K173409 | Wireless Audio System | Feb 16, 2018 | Substantially Equivalent |
| K173377 | 3.0T 16ch Breast Coil | Nov 28, 2017 | Substantially Equivalent |
| K160350 | ECG CT Gating Device | Jun 16, 2016 | Substantially Equivalent |
| K141832 | 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE | Jul 31, 2014 | Substantially Equivalent |
| K133670 | HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE | Jul 24, 2014 | Substantially Equivalent |
| K133422 | 1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE | Dec 26, 2013 | Substantially Equivalent |