AccessGUDID - DEVICE: Rho (06287194090220)

GUDID

Device Identifier (DI) Information

Brand Name: Rho
Version or Model: Rho
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 16 Bit Inc.

Primary DI Number: 06287194090220
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203879963 *Terms of Use

Device Description: Rho radiology software for opportunistic evaluation of low bone mineral density.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63386	X-ray image interpretive software	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].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
SAO	Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN230023	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 980f8d2d-fd1a-4cde-acbe-e215a2c44a9b
Public Version Date: April 08, 2025
Public Version Number: 1
DI Record Publish Date: March 31, 2025