FDA.reportPublic FDA data

SubtleALIGN

Primary DI
00860000171236
Brand
SubtleALIGN
Company
Subtle Medical, Inc.
Model
1.x
Device description
SubtleALIGN is a radiology image reformatting software that is intended to automatically align 3-dimensional brain MR images to consistent anatomical orientations (axial, coronal, and sagittal).
Published
2026-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K233699000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233699000SubtleREFORMAT (1.x)Subtle Medical, Inc.2024-04-29LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000171236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000171236008600001712368600001712360860000171236

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

Regulatory Flags#

DUNS number
081069974
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860000171229SubtleSYNTH1.x2026-04-09
00860000171243SubtleHD(MR)1.x2026-04-09
00860000171298AiMIFY1.x2026-04-09
00860000171205SubtlePET2.x2022-04-29
00860000171212SubtleMR2.x2022-04-29

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Primary DI, Brand, Company table
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00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05