FDA.reportPublic FDA data

SubtleHD(MR)

Primary DI
00860000171243
Brand
SubtleHD(MR)
Company
Subtle Medical, Inc.
Model
1.x
Device description
SubtleHD is an image processing software that can be used for image enhancement of all body parts MRI images. It can be used for noise reduction and increasing image sharpness.
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
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243250000SubtleHD (1.x)Subtle Medical, Inc.2025-02-12QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000171243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000171243008600001712438600001712430860000171243

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
00860000171236SubtleALIGN1.x2026-04-09
00860000171298AiMIFY1.x2026-04-09
00860000171205SubtlePET2.x2022-04-29
00860000171212SubtleMR2.x2022-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013056506Cirrus Software ApplicationSORA NEUROSCIENCE, INC.QIH2026-10-26
00850018318020Bladder AIExo Imaging, Inc.QIH2026-10-22
00850018318075AI Platform IIExo Imaging, Inc.QIH2026-10-22
00850018318082Strain AIExo Imaging, Inc.QIH2026-10-22
03770033463055FETOLYDIAGNOLYQIH2026-10-22
05745000308361Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual ExCercare Medical A/SQIH2026-10-16
19356870000069PHA4DMEDICAL LIMITEDQIH2026-10-13
00198953083246VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953200421EchoPACGE Vingmed Ultrasound A/SQIH2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SQIH2026-10-07
04262352357645DS Core DiagnosisZetta25 AGQIH2026-10-06
00860006442651cmAngioCuremetrix, Inc.QIH2026-10-05
08809887550170EdgeFlow UH10CEdgeCare Inc.QIH2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.QIH2026-09-30
00195278985613NAGE Medical Systems (China) Co.,Ltd.QIH2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SQIH2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.QIH2026-09-18
B720BX360HYPERDENSI1440Brainomix 360 HyperdensityBRAINOMIX LIMITEDQIH2026-09-18
00860016420922AI-CVDHeart Lung CorporationQIH2026-09-04
04262352350059DS Core CBCT AnatomyZetta25 AGQIH2026-08-26
00884838129924AV Cardiovascular Suite V1Philips Medical Systems Nederland B.V.QIH2026-08-23
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18