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
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
SAORadiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAORadiology Software For Opportunistic Evaluation Of Low Bone Mineral DensityRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230023000Rho16 Bit, Inc.2024-04-09SAO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06287194090220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06287194090220062871940902206287194090220

GMDN Terms#

Term, Definition table
TermDefinition
X-ray image interpretive softwareAn 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].

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628719409022RhoRho2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628719409022Rho16 Bit Inc.SAO2026-06-05