# Neocoil, LLC

- Location (FDA's records): Pewaukee, WI
- FDA decisions: 21 (2007–2026): 21 510(k) clearances
- Names in FDA's records: Neocoil, LLC (17); Neocoil (4)
- Product codes: MOS (18), LNH (2), JAK (1)
- 510(k) review time since 2016: median 53 days, against 71 for FDA's reviews in the same codes and years (6 of 8 faster)
- Predicates its devices cite: 25 (12 its own); citations of its devices by later devices: 17 (12 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Usa Instruments, Inc.: 4 (https://510kreport.com/company/usa-instruments)
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)
- Igc-Medical Advances, Inc.: 1 (https://510kreport.com/company/igc-medical-advances)
- Invivo Corporation: 1 (https://510kreport.com/company/invivo)
- Medical Advances, Inc.: 1 (https://510kreport.com/company/medical-advances)
- Toshiba America Medical Systems, In.C: 1 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)
- Ge Healthcare Coils (Usa Instruments, Inc.): 1 (https://510kreport.com/company/ge-healthcare-coils-usa-instruments)
- Machnet BV: 1 (https://510kreport.com/company/machnet)

## Firms that cite its devices most
- Shenzhen RF Tech Co., Ltd.: 3 (https://510kreport.com/company/shenzhen-rf-tech)
- Quality Electrodynamics, LLC: 1 (https://510kreport.com/company/quality-electrodynamics)
- Innovere Medical, Inc.: 1 (https://510kreport.com/company/innovere-medical)

## Its most-cited devices
- K121362: 1.5T 16CH Flex Speeder Large (2012), cited by 4
- K173377: 3.0T 16ch Breast Coil (2017), cited by 2
- K113474: 1.5T Gem Flex Coil (2012), cited by 2
- K101632: Metaflexcoil (2010), cited by 2
- K071311: Neocoil 1.5T 8-Channel Shoulder Array Coil (2007), cited by 1
- K071611: Neocoil 3.0T 8-Channel Shoulder Array Coil (2007), cited by 1

## Recent decisions
- K260947: 0.55T 12Ch Breast Coil (Apr 23, 2026)
- 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)
- 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)
- K201101: 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil (Jun 2, 2020)
- K182958: 1.5T 16ch Breast Coil (Nov 16, 2018)
- K173409: Wireless Audio System (Feb 16, 2018)
- K173377: 3.0T 16ch Breast Coil (Nov 28, 2017)
- K160350: ECG CT Gating Device (Jun 16, 2016)

Source page: https://510kreport.com/company/neocoil