NeoCoil, LLC
FDA Regulatory Profile
NeoCoil, LLC appears in FDA public data with 2 recalls, 21 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2312-2016, Class II) was initiated on June 17, 2016. Its most recent 510(k) clearance was granted on April 23, 2026.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 21
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2312-2016 | Class II | 3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-2 | June 17, 2016 |
| Z-1027-2016 | Class II | NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and | December 18, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260947 | 0.55T 12Ch Breast Coil | April 23, 2026 |
| K222407 | 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast | October 14, 2022 |
| K213687 | 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior | March 11, 2022 |
| K201101 | 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil | June 2, 2020 |
| K182958 | 1.5T 16ch Breast Coil | November 16, 2018 |
| K173409 | Wireless Audio System | February 16, 2018 |
| K173377 | 3.0T 16ch Breast Coil | November 28, 2017 |
| K160350 | ECG CT Gating Device | June 16, 2016 |
| K141832 | 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE | July 31, 2014 |
| K133670 | HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE | July 24, 2014 |
| K133422 | 1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE | December 26, 2013 |
| K123272 | 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM | March 28, 2013 |
| K121362 | 1.5T 16CH FLEX SPEEDER LARGE | June 15, 2012 |
| K113474 | 1.5T GEM FLEX COIL | March 16, 2012 |
| K103342 | 3.0T METAFLEXCOIL | December 23, 2010 |
| K101632 | METAFLEXCOIL | August 24, 2010 |
| K073236 | NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE | November 30, 2007 |
| K073181 | NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL | November 21, 2007 |
| K071611 | NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL | June 28, 2007 |
| K071311 | NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL | May 22, 2007 |