FDA UDI
In Commercial Distribution
🇺🇸 United States
Autoplaque
DI: 00860014730009
·
Model: 3
·
APQ HEALTH INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Autoplaque
- Primary DI
- 00860014730009
- Version / Model
- 3
- Company Name
- APQ HEALTH INC.
- Labeler DUNS
- 138348194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-12
- Public Version
- 1
- Public Version Date
- 2025-12-22
- Public Version Status
- New
- Public Device Record Key
- afe0afbc-567f-4e0d-b965-cc0c53cb7486
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57812 | Radiology DICOM image processing application software | A 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860014730009 | GS1 |
Customer Contacts
- Phone
- 13109877842
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212758 | 000 |