FDA.reportPublic FDA data

MICSI-PET

Primary DI
00860013868918
Brand
MICSI-PET
Company
MicroStructure Imaging, Inc.
Model
1
Device description
MICSI-PET is an image processing software that can be used for image enhancement in PET images. It computes quantitative metrics including regional SUVr (Standardized Uptake Value ratio), Centiloid scores for amyloid and tau PET, and z-scores compared to normative controls.
Published
2026-10-14
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

Product Codes#

Code, Name table
CodeName
KPSSystem, Tomography, Computed, Emission
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPSSystem, Tomography, Computed, EmissionRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261305000MICSI-PETMicrostructure Imaging, Inc.2026-09-11KPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013868918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013868918008600138689188600138689180860013868918

Regulatory Flags#

DUNS number
081151542
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
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
00860013868901MICSI-RMT12025-04-30

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Primary DI, Brand, Company table
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