FDA.reportPublic FDA data

EVOLVE

Primary DI
G775EVOLVE4140
Brand
EVOLVE
Company
Smaart Medical Systems, Inc.
Model
4.1.4
Device description
Picture archiving and communication system (PACS) software that retrieves, archives, distributes, and displays images and data from all common modalities.
Published
2026-07-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211863000eVolve PACSEvolve Pacs, Inc.2021-08-12LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G775EVOLVE4140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Contacts#

Phone, Email table
PhoneEmail
972-934-4600kim.terry@smaart.net

Regulatory Flags#

DUNS number
143044274
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G775EVOLVE4130EVOLVE4.1.32026-01-29
G775EVOLVE0EVOLVE4.1.22025-06-13

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Primary DI, Brand, Company table
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