OmniTom
FDA 510(k) K171183 · Neurologica Corporation
510(k) numberK171183
Submission
- Device name
- OmniTom
- Applicant
- Neurologica Corporation
Danvers, MA, US - Received
- April 24, 2017
- Decision date
- August 18, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
| K253450 | BodyTom Elite (NL4000)JAK · Traditional | NeuroLogica Corp., a Samsung Company | 07/28/2026SE |
| K253770 | CardIQ SuiteJAK · Traditional | GE Medical Systems SCS | 07/21/2026SE |
| K253560 | Enhanced Boundary for PCCTJAK · Traditional | Ge Medical Systems, LLC | 06/24/2026SE |
| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | Varian Medical Systems, Inc. | 06/04/2026SE |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | Canon Medical Systems Corporation | 05/20/2026SE |
| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
| K253686 | True Definition DLJAK · Traditional | Ge Healthcare Japan Corporation | 03/23/2026SE |
| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250928 | OmniTom Elite with PCDJAK · Traditional | 09/08/2025SE |
| K233767 | OmniTom EliteJAK · Traditional | 06/10/2024SE |
| K213649 | BodyTom 64JAK · Traditional | 04/29/2022SE |
| K142697 | NExCT 7JAK · Traditional | 12/23/2014SE |
| K102677 | Bodytom NL 4000JAK · Traditional | 03/24/2011SE |
| K090811 | Inspira HD, Model: NL1000KPS · Abbreviated | 08/27/2009SE |
| K051765 | Ceretom, Model NL3000JAK · Traditional | 07/14/2005SE |
Questions and answers
When was OmniTom cleared by the FDA?
OmniTom (K171183) received a 510(k) decision of Substantially Equivalent on August 18, 2017, 116 days after the submission was received.
What is the product code of K171183?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.