Model: 14.3
DI: B720BX360EASPECTS1430
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
34c5d105-16c6-4f4a-b395-945831416ff6
Distribution Status:
In Commercial Distribution
DUNS Number:
216967482
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B720BX360EASPECTS1430
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 63386
Name: X-ray image interpretive software
Definition:
An interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].
FDA Product Codes
POK
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Premarket Submissions
Submission Number:
K243294
Supplement Number:
000