Ceretom, Model NL3000
FDA 510(k) K051765 · Neurologica Corporation
510(k) numberK051765
Submission
- Device name
- Ceretom, Model NL3000
- Applicant
- Neurologica Corporation
Danvers, MA, US - Received
- June 30, 2005
- Decision date
- July 14, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
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| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
More from Siemens Medical Solutions USA, Inc.
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| K250928 | OmniTom Elite with PCDJAK · Traditional | 09/08/2025SE |
| K233767 | OmniTom EliteJAK · Traditional | 06/10/2024SE |
| K213649 | BodyTom 64JAK · Traditional | 04/29/2022SE |
| K171183 | OmniTomJAK · Traditional | 08/18/2017SE |
| K142697 | NExCT 7JAK · Traditional | 12/23/2014SE |
| K102677 | Bodytom NL 4000JAK · Traditional | 03/24/2011SE |
| K090811 | Inspira HD, Model: NL1000KPS · Abbreviated | 08/27/2009SE |
Questions and answers
When was Ceretom, Model NL3000 cleared by the FDA?
Ceretom, Model NL3000 (K051765) received a 510(k) decision of Substantially Equivalent on July 14, 2005, 14 days after the submission was received.
What is the product code of K051765?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.