FDA.report

AccessNET

Primary DI
B433AN0
Brand
AccessNET
Company
ASPYRA, LLC
Model
7
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions

SubmissionSupplement
K091631000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K091631000ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEWAspyra, Inc.2010-03-18LLZ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B433AN0PrimaryHIBCC0

GMDN Terms

TermDefinition
Radiology 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. It is designed specifically for use within radiology.

Sterilization Methods

Method

Regulatory Flags

DUNS number
042810871
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
B433CL0CyberLAB7.3.1CL7312022-10-12
B433AN710AccessNET7.1.02016-09-29

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