Model: 1
DI: 05060508820062
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-15
Description
X-ray Specimen Imaging Cabinet
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
3
Record Key:
4c4c4df1-5bc7-459a-9194-6beba4bd1533
Distribution Status:
In Commercial Distribution
DUNS Number:
216744109
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:
05060508820062
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 42280
Name: Tissue specimen x-ray system IVD
Definition:
An assembly of devices designed to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption patterns of the x-rays. The system typically includes a cabinet where the specimen is placed and a screen; the image is generated via digital imaging methods.
FDA Product Codes
MWP
Cabinet, X-Ray System
Premarket Submissions
Submission Number:
K213691
Supplement Number:
000