OmniTom Elite PCD
OmniTom Elite PCD is a mobile computed-tomography system using a photon-counting detector. It images anatomy that fits within a 40 cm aperture, primarily the head and neck. The system has…
OmniTom Elite PCD is a mobile computed-tomography system using a photon-counting detector. It images anatomy that fits within a 40 cm aperture, primarily the head and neck. The system has 16 detector rows and a 30 cm field of view, with a translating gantry on powered wheels.
Adult and pediatric imaging is indicated, with preset dose settings based on weight and age. Examinations may use contrast or proceed without it. The detector acquires simultaneous data in multiple energy bands using configurable energy thresholds.
Spectral Imaging and Power
Multi-energy data support material decomposition and virtual monoenergetic images. Batteries power the system while it is unplugged for mobility. The gantry contains the X-ray generator, data acquisition and reconstruction components, with interlocks, emergency stop and alignment lasers supporting operation.
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Neusoft Medical Systems Co., Ltd. | Shenyang | Liaoning | Manufacturer | 1 |
| Philips Health Technology (China) Co., Ltd. Shenyang Branch | Shenyang | Liaoning | Specification developer | 1 |
Record
| Listed by | Neurologica Corporation, United States |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| 510(k) | K250928 |
| Record published | 2023-07-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0-NL5000-003 | In distribution | |
| 0-NL5100-001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Visicoil | IZI Medical Products LLC | 48 |
| Visicoil MR | IZI Medical Products LLC | 41 |
| Illumisite | Covidien LP | 25 |
| Imbio LDA | Imbio, LLC | 24 |
| Edge | Covidien LP | 20 |
| Revolution | GE Hangwei Medical Systems Co., Ltd. | 20 |
| Gold Fiducial | IZI Medical Products LLC | 20 |
| superDimension | Covidien LP | 17 |
| Lodox | Lodox Systems (PTY) Ltd. | 12 |
| Revolution | GE Medical Systems, L.L.C. | 12 |
| Toshiba Scanner | Canon Inc. | 10 |
| syngo.CT Dual Energy | Siemens Healthcare Limited | 7 |
Showing 12 of 495. All products under System, X-Ray, Tomography, Computed
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250928 | 2025-09-08 |
| K233767 | 2024-06-10 |
| K213649 | 2022-04-29 |
| K171183 | 2017-08-18 |
| K142697 | 2014-12-23 |
| K102677 | 2011-03-24 |
| K051765 | 2005-07-14 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.