FDA.reportPublic FDA data

Tempus Pixel

Primary DI
B664AMM71
Brand
Tempus Pixel
Company
Arterys Inc.
Model
AMM7
Published
2025-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203744000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203744000Arterys MICAArterys, Inc.2022-03-14QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B664AMM70PreviousHIBCC0
B664AMM71PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-739-4137support@tempus.com

Regulatory Flags#

DUNS number
078466835
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B664AMM70Arterys MICAAMM72022-11-14
B664AMM60Arterys MICAAMM62020-07-03
08624310003104Arterys Cardio DLCVM22017-03-15
08624310003203Arterys Viewer AVM32017-11-01
B664AMM50Arterys MICAAMM52019-06-25
B664AOM40Arterys Oncology DLAOM42018-06-22
B664AVM30Arterys ViewerAVM32018-06-23
B664CVM20Arterys Cardio DLCVM22018-06-23

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Primary DI, Brand, Company table
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04068151086584LungMapsSiemens Healthineers AGQIH2026-06-24
00850631008872Roentgen WorksBrit Systems, LLCLLZ2026-06-23
04068151049923MI View&GOSIEMENS MEDICAL SOLUTIONS USA, INC.QIH2026-06-10
00628184004500Intellijoint VIEWIntellijoint Surgical IncLLZ2026-06-09
00860005144082Brain AgeDeephealth, Inc.LLZ2026-06-08
07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
07649997938052Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08