Autoplaque

Primary DI
00860014730009
Brand
Autoplaque
Company
APQ HEALTH INC.
Model
3
Device description
Autoplaque software performs post-processing of coronary Computed Tomography Angiography (CTA) images and measurements of components of images using computerized algorithms. The software supports current clinical workflow and enhances quantitative analysis of coronary CTA images. The software aids the physician with measurement of coronary artery stenosis and provides measurements for coronary plaque and coronary artery remodeling.
Published
2025-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K212758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212758000AutoplaqueCedars-Sinai Medical Center: Aim2023-05-19LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014730009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014730009008600147300098600147300090860014730009

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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
13109877842support@apqhealth.com

Regulatory Flags#

DUNS number
138348194
Device count
1

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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