AURA 10 PET-CT

Primary DI
05430002734026
Brand
AURA 10 PET-CT
Company
Xeos Medical
Model
A
Device description
Cabinet system that includes Emission Computed Tomography (PET) with or without x-ray (e.g., CT) imaging including the software/hardware necessary to reconstruct the image and display to the end user
Published
2024-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QXLCabinet, Emission Computed Tomography System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QXLCabinet, Emission Computed Tomography SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231420000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231420000Aura 10 PET/CTXeos Medical2023-08-10QXL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15430002734023PackageGS11In Commercial Distribution
05430002734026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1543000273402315430002734023
05430002734026054300027340265430002734026

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/analyser specimen/reagent container carrier IVDA device intended to hold a specimen/reagent container (e.g., test tube, tissue specimen petri dish, microplate, cuvette) on board an in vitro diagnostic laboratory instrument or analyser (e.g., PCR machine, spectrophotometric plate reader, biopsy specimen analyser, automated liquid handling station). It may be in the form of a removable tray (excludes immunoassay vehicle trays), holder, shuttle, rack/rack base, slotted case, or other format suitable to be handled and loaded into the parent device by the operator or via an automated process. This is a reusable device.

Regulatory Flags#

DUNS number
371941719
Device count
1
Serial number
true
Manufacturing date on label
true