E.CAM Computer / E.Soft Workstation
by Siemens Medical Solutions USA, Inc.
510(k) K023190
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023190 | Date24 Oct 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The E.CAM Computer / E.Soft Workstation is a Gamma Camera computer designed for nuclear medicine imaging. It processes and displays radionuclide distribution within the body or specific organs using planar imaging, whole-body imaging, single-photon emission computed tomography (SPECT) for non-positron emitters, and positron imaging techniques—both coincidence and non-coincidence methods.
This device is intended for use in radiology settings as part of advanced image processing systems. Supplied as a standalone workstation, it requires no sterilisation and is classified as a reusable medical device. The system adheres to MRI safety guidelines for non-MRI environments and is authorised under FDA 510(k) clearance (K023190) for radiological image processing applications, falling under the LLZ product code classification.
Other devices from Siemens Medical Solutions USA, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the E.CAM Computer / E.Soft Workstation used for?
The E.CAM Computer / E.Soft Workstation is designed for nuclear medicine imaging, processing and displaying radionuclide distribution in the body or specific organs. It supports planar imaging, whole-body imaging, single-photon emission computed tomography (SPECT) for non-positron emitters, and positron imaging—both coincidence and non-coincidence methods. This makes it ideal for advanced radiology applications where detailed nuclear imaging is required.
Is the E.CAM Computer / E.Soft Workstation reusable or single-use?
The E.CAM Computer / E.Soft Workstation is classified as a reusable medical device. Since it is a standalone workstation and not a disposable component, it is intended for repeated use in clinical settings, provided it is maintained according to manufacturer guidelines.
Does the E.CAM Computer / E.Soft Workstation require sterilization?
No, the E.CAM Computer / E.Soft Workstation does not require sterilization. As a reusable workstation designed for radiology imaging, it is intended to be cleaned and maintained in accordance with standard medical device protocols, rather than subjected to sterilization procedures.
What types of imaging techniques does it support?
The E.CAM Computer / E.Soft Workstation supports multiple imaging techniques, including planar imaging, whole-body imaging, single-photon emission computed tomography (SPECT) for non-positron emitters, and positron imaging—both coincidence and non-coincidence methods. This versatility allows clinicians to perform a wide range of nuclear medicine studies.
How is the E.CAM Computer / E.Soft Workstation supplied and where is it used?
The E.CAM Computer / E.Soft Workstation is supplied as a standalone workstation, meaning it is not part of a kit or bundled with additional hardware. It is intended for use in radiology settings as part of advanced image processing systems, where nuclear imaging and detailed radionuclide analysis are conducted.