Cabinet, Emission Computed Tomography System
The cabinet emission computed tomography system (product code QXL) is a Class 2 Radiology device (regulation 892.1200) designed to obtain emission computed tomography imaging (PET, SPECT, or gamma camera, with or without CT) of harvested tissue specimens from various anatomical regions to verify that the correct tissue has been excised during surgical procedures. Requiring 510(k) clearance, it supports intraoperative specimen verification. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QXL
- Device Class
- FDA class 2
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
Definition
Obtain Emission Computed Tomography (PET, SPECT or Gamma Camera) with or without x-ray (e.g., CT) imaging of harvested specimens from various anatomical regions in order to provide verification that the correct tissue has been excised during surgical procedures
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231420 | Aura 10 PET/CT | Aug 10, 2023 | Substantially Equivalent | Xeos Medical |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.