FDA.reportPublic FDA data

HealthPNX

Primary DI
07290018016077
Brand
HealthPNX
Company
NANO-X AI LTD
Model
2.0.0
Published
2020-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QFMRadiological Computer-Assisted Prioritization Software For Lesions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFMRadiological Computer-Assisted Prioritization Software For LesionsRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190362000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190362000HealthPNXZebra Medical Vision, Ltd.2019-05-06QFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018016077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018016077072900180160777290018016077

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600098228
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290018016206HealthOST1.22025-12-14
07290018016176HealthCCSng2.12025-02-19
07290018016152HealthFLD1.02024-11-21
07290018016169HealthCCSng2.02024-11-21
07290018016145HealthOST1.12023-05-09
07290018016138HealthCCSng1.12023-05-04
07290018016114HealthOST1.12022-08-01
07290018016107HealthPPT1.02021-12-30
07290018016091HealthCCSng1.02021-10-18
07290018016060HealthMammo2.22020-09-21
07290018016084HealthVCF1.02020-09-21
07290018016053HealthICH3.0.02020-03-06
07290018016046HealthCXR1.0.02020-01-03
07290018016039HealthICH2.1.32020-01-01
07290018016022HealthICH2.0.52019-07-02
07290018016015HealthPNX1.0.62019-05-12
07290018016008HealthCCS3.0.02019-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007434716Cognet AIMedcognetics IncQFM2026-05-21
07290018052365BriefCase TriageAIDOC MEDICAL LTDQFM2026-02-15
G140ANNALISECONTAINER60Annalise Critical Care AIHARRISON-AI MEDICAL PTY LTDQFM2025-07-28
G140ANNALISEENTP60Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2025-07-24
G140ANNALISECONTAINER70Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2025-07-02
M722X25122P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-06-17
M722XC25114P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-06-17
M722XD25114P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-06-17
B761R60Rapid Ischemaview, Inc.QFM2025-05-07
03770024774016SmartChestMILVUEQFM2025-03-31
M722X25064P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-03-27
M722XC25064P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-03-27
M722XD25064P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-03-27
07290018052273BriefCase TriageAIDOC MEDICAL LTDQFM2024-11-24
07290018052297BriefCase TriageAIDOC MEDICAL LTDQFM2024-11-24
08800045800342VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVUNO Inc.QFM2024-11-19
B826CINAVCF100CINA-VCFAVICENNA.AIQFM2024-06-20
M722XD24079P212210ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2024-04-15
08800076000179Lunit INSIGHT CXR TriageLunit Inc.QFM2024-04-09
B761R51020RapidIschemaview, Inc.QFM2024-02-13
B761R610RapidIschemaview, Inc.QFM2024-02-13
G140ANNALISEENTP50Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2024-01-11
07290018052259BriefCase TriageAIDOC MEDICAL LTDQFM2023-12-27
G140ANNALISEENTP40Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2023-11-06
00860006442668cmTriageCuremetrix, Inc.QFM2023-10-31
00850057636017qXR-PTX-PEQURE.AI TECHNOLOGIES PRIVATE LIMITEDQFM2023-10-10
00860007434709Cognet AIMedcognetics IncQFM2023-09-11
G140ANNALISEENTP30Annalise EnterpriseHARRISON-AI MEDICAL PTY LTDQFM2023-07-24
07290018052211BriefCase TriageAIDOC MEDICAL LTDQFM2023-07-14
G140ANNALISEENTP20Annalise EnterpriseHARRISON-AI MEDICAL PTY LTDQFM2023-06-08