FDA.report

AKUNAH REFLECT

Primary DI
09309002093005
Brand
AKUNAH REFLECT
Company
AKUNAH PTY LTD
Model
REFLECT
Device description
Akunah Reflect Planning Software
Published
2025-03-25
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

Product Codes

CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications

CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions

SubmissionSupplement
K222987000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K222987000Akunah REFLECTAkunah Pty, Ltd.2023-05-10LLZ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09309002093005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09309002093005093090020930059309002093005

GMDN Terms

TermDefinition
Orthopaedic/craniofacial implantation planning softwareA software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.

Sterilization Methods

Method

Regulatory Flags

DUNS number
748490069
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
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

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