Rho

Primary DI: 06287194090220
Brand: Rho
Company: 16 Bit Inc.
Model: Rho
Device description: Rho radiology software for opportunistic evaluation of low bone mineral density.
Published: 2025-03-31
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: false
Single use: false

Related Records

Product Codes

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

Product Code Classifications

Code	Device	Specialty	Class
SAO	Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density	Radiology	2

Premarket Submissions

Submission	Supplement
DEN230023	000

Premarket Details

Submission	Supplement	Device	Applicant	Decision date	Product code
DEN230023	000	Rho	16 Bit, Inc.	2024-04-09	SAO

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
06287194090220	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
06287194090220	06287194090220	6287194090220

GMDN Terms

Term	Definition
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].

Term

Definition

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].

Sterilization Methods

Method

Regulatory Flags

DUNS number: 203879963
Device count: 1
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: false
Combination product: false
Lot or batch: false
Serial number: false
Manufacturing date on label: false
Expiration date on label: false
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false