# Neurologica Corporation

- Location (FDA's records): Danvers, MA
- FDA decisions: 8 (2005–2025): 8 510(k) clearances
- Product codes: JAK (7), KPS (1)
- 510(k) review time since 2016: median 163 days, against 136 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 15 (6 its own); citations of its devices by later devices: 14 (6 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
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)
- Union Carbide Corp.: 1 (https://510kreport.com/company/union-carbide)
- Neurologica Corporation, A Subsidiary of Samsung Electronics: 1 (https://510kreport.com/company/neurologica-a-subsidiary-of-samsung-electronics)
- Analogic Corp.: 1 (https://510kreport.com/company/analogic)
- Siemens Corp.: 1 (https://510kreport.com/company/siemens)
- Hitachi Medical Systems America, Inc.: 1 (https://510kreport.com/company/hitachi-medical-systems-america)
- Neurologica Corporation, A Subsidiary of Samsung: 1 (https://510kreport.com/company/neurologica-a-subsidiary-of-samsung)
- Toshiba America Medical Systems, In.C: 1 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)

## Firms that cite its devices most
- Neurologica Corporation, A Subsidiary of Samsung Electronics: 3 (https://510kreport.com/company/neurologica-a-subsidiary-of-samsung-electronics)
- Xoran Technologies, Inc.: 1 (https://510kreport.com/company/xoran-technologies)
- Neurologica Corporation, A Subsidiary of Samsung: 1 (https://510kreport.com/company/neurologica-a-subsidiary-of-samsung)
- Mobius Imaging, LLC: 1 (https://510kreport.com/company/mobius-imaging)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Samsung HME America, Inc., dba NeuroLogica Corp.: 1 (https://510kreport.com/company/samsung-hme-america-dba-neurologica)

## Its most-cited devices
- K051765: Ceretom, Model NL3000 (2005), cited by 6
- K102677: Bodytom NL 4000 (2011), cited by 3
- K233767: OmniTom Elite (2024), cited by 2
- K090811: Inspira HD, Model: NL1000 (2009), cited by 1
- K213649: BodyTom 64 (2022), cited by 1
- K171183: OmniTom (2017), cited by 1

## Recent decisions
- K250928: OmniTom Elite with PCD (Sep 8, 2025)
- K233767: OmniTom Elite (Jun 10, 2024)
- K213649: BodyTom 64 (Apr 29, 2022)
- K171183: OmniTom (Aug 18, 2017)
- K142697: NExCT 7 (Dec 23, 2014)
- K102677: Bodytom NL 4000 (Mar 24, 2011)
- K090811: Inspira HD, Model: NL1000 (Aug 27, 2009)
- K051765: Ceretom, Model NL3000 (Jul 14, 2005)

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