ENDOPRO IQ

GUDID 04961333243891

HITACHI SONOELASTOG SOFTWR/HV PREIRUS-B

PENTAX OF AMERICA, INC.

Diagnostic imaging telemedicine system

• Primary Device ID: 04961333243891
• NIH Device Record Key: 5d153acc-17ae-4785-adf5-def663e232dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOPRO IQ
• Version Model Number: M70228
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333243891 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093466

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-14

On-Brand Devices [ENDOPRO IQ]

• 04961333243938: IQ ADVANCED ANALYTICS (5 TOKENS)
• 04961333243921: ENDOPRO IQ DOD SITE LICENSE (PER SITE)
• 04961333243914: IQ ADVANCED ANALYTICS (3 TOKENS)
• 04961333243907: IQ ANALYTICS 5 USER LICENSE PACK
• 04961333243891: HITACHI SONOELASTOG SOFTWR/HV PREIRUS-B
• 04961333243884: MICROSOFT SQL RUNTIME
• 04961333243877: MICROSOFT SQL STANDARD EDITION
• 04961333243860: MICROSOFT SQL ENTERPRISE EDITION
• 04961333243853: PATHOLOGY SYSTEM INTERFACE
• 04961333243846: PATHOLOGY SYSTEM INTERFACE
• 04961333243839: VITALS MONITOR INTERFACE
• 04961333243822: VITALS MONITOR INTERFACE
• 04961333243815: HL7 OUTBOUND INTERFACE (UNC/PDF)
• 04961333243808: HL7 OUTBOUND INTERFACE UNC/PDF ADD-ON
• 04961333243792: HL7 OUTBOUND INTERFACE (ORU)
• 04961333243785: HL7 OUTBOUND INTERFACE (ORU)
• 04961333243778: HL7 INBOUND INTERFACE (ADT/SIU/ORM)
• 04961333243761: HL7 INBOUND INTERFACE (ADT/SIU/ORM)
• 04961333243754: ENDOPRO IQ REVIEW LICENSE (UNLIMITED)
• 04961333243747: ENDOPRO IQ REVIEW LICENSE (UNLIMITED)
• 04961333243730: ENDOPRO IQ REVIEW LICENSE (20-30)
• 04961333243723: ENDOPRO IQ REVIEW LICENSE (20-30)
• 04961333243716: ENDOPRO IQ REVIEW LICENSE (10-19)
• 04961333243709: ENDOPRO IQ REVIEW LICENSE (10-19)
• 04961333243693: ENDOPRO IQ REVIEW LICENSE (1-4)
• 04961333243686: ENDOPRO IQ REVIEW LICENSE (1-4)
• 04961333243679: NURSING NOTES
• 04961333243662: NURSING NOTES
• 04961333243655: DOC-U-SCRIBE REPORTING
• 04961333243648: DOC-U-SCRIBE REPORTING
• 04961333243631: MPS VIDEO CAPTURE
• 04961333243624: MPS VIDEO CAPTURE
• 04961333243617: ENDOREMOTE
• 04961333243600: ENDOREMOTE
• 04961333243594: ENDOPRO IQ (PER OR ROOM)
• 04961333243587: ENDOPRO IQ (PER OR ROOM)
• 04961333243570: ENDOPRO IQ (PER MOBILE CART)
• 04961333243563: ENDOPRO IQ (PER MOBILE CART)
• 04961333243556: ENDOPRO IQ AMBULATORY SITE LICENSE
• 04961333243549: ENDOPRO IQ AMBULATORY SITE LICENSE
• 04961333243532: ENDOPRO IQ HOSPITAL SITE LICENSE
• 04961333243525: ENDOPRO IQ HOSPITAL SITE LICENSE
• 04961333243518: ENDOPRO IQ CAPTURE LICENSE
• 04961333243501: ENDOPRO IQ CAPTURE LICENSE
• 04961333243495: ENDOPRO IQ REVIEW LICENSE (5-9)
• 04961333243488: ENDOPRO IQ REVIEW LICENSE (5-9)
• 04961333243471: ENDOPRO IQ CITRIX/VIRTUALIZATION LICENSE
• 04961333243464: ENDOPRO IQ CITRIX/VIRTUALIZATION LICENSE
• 04961333243457: POWER SUPPLY -NDS 32" SPLIT SCREEN MON.
• 04961333243440: MATROX ORION HD CAPTURE CARD