FDA.reportPublic FDA data

EXINI Bone

Primary DI
07350002333037
Brand
EXINI Bone
Company
Exini Diagnostics AB
Model
03
Catalog number
303
Device description
EXINI bone is a stand alone software intended for Windows OS platform. Users of the device can import whole body bone scintigraphy image data, view it using 2D medicalimage viewers, view and export quantitative analysis values.
Published
2023-04-06
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191262000aBSIExini Diagnostics AB2019-08-05LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350002333037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350002333037073500023330377350002333037

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+46462865420support@exini.com

Regulatory Flags#

DUNS number
631535262
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350002336021PYLARIFY AI026022022-09-09
07350002337028aPROMISE027022023-03-29
07350002336014PYLARIFY AI016012021-11-16
07350002335017aPROMISE015012021-08-04
07350002332030aBSI032032019-10-08
07350002331033EXINI31032016-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
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00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26