FDA.report

Arterys MICA

Primary DI
B664AMM60
Brand
Arterys MICA
Company
Arterys Inc.
Model
AMM6
Published
2020-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions

SubmissionSupplement
K192437000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K192437000Arterys MICAArterys, Inc.2020-03-25QIH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B664AMM60PrimaryHIBCC0

GMDN Terms

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 manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods

Method

Contacts

PhoneEmail
800-739-4137support@tempus.com

Regulatory Flags

DUNS number
078466835
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B664AMM71Tempus PixelAMM72025-03-06
B664AMM70Arterys MICAAMM72022-11-14
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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