BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FIBER GRAPHICS EXTENSION RECEIVER (68395)

    Reg #: 2518897 · FEI: 1000080301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    103
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PENTAX of America, Inc.
    Registration Number
    2518897
    FEI Number
    1000080301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3 Paragon Drive
    City
    MONTVALE
    State
    NJ
    ZIP
    07645
    Country
    US

    Owner / Operator

    Firm Name
    HOYA Corporation PENTAX Division
    Operator Number
    8030235
    Address
    3 Paragon Drive
    City
    Montvale
    State
    NJ
    Postal Code
    07645
    Country
    US
    Correspondent
    Gurvinder Nanda

    Products

    Device Name Product Code
    Medical Device Data System OUG

    Proprietary Names

    FIBER GRAPHICS EXTENSION RECEIVER (68395) FOOTSWITCH: MPS THREE PEDAL (68354) FOOTSWITCH: MPS SINGLE PEDAL (90108) ENDOPRO IQ CITRIX/VIRTUALIZATION LICENSE (M70204) SCAN CONVERTER (7138) HL7 OUTBOUND INTERFACE, UNC/PDF (M70222-UP) ASSY: SERVER, RACK MOUNT FORM FACTOR (KBM68312) IMAGE CAPTURE PC (KBM68406) ASSY: REVIEW/SCHEDULING PC (KBM68307) IQ ADVANCED ANALYTICS, 3 TOKENS (M70230) DOC-U-SCRIBE REPORTING (M70213-UP) MICROSOFT SQL STANDARD EDITION (M70226) COMPUTER DIGITAL VIDEO SYSTEM (7245D) NURSING NOTES (M70214) MPS VIDEO CAPTURE (M70212-UP) ENDOPRO IQ REVIEW LICENSE, 1-4 (M70216) ENDOPRO IQ REVIEW LICENSE, 20-30 (M70218) ENDOPRO IQ DOD SITE LICENSE, PER SITE (M70234) ENDOPRO IQ REVIEW LICENSE, 5-9 (M70205-UP) ASSY: MPS DV/SD CAPTURE (KBM68303) DATA INTERFACE: OLYMPUS/FUJINON (68384) MICROSOFT SQL ENTERPRISE EDITION (M70225) ENDOREMOTE (M70211-UP) DICOM COMPLIANCE MODULE FOR STROBOSCOPY (9251) ENDOPRO IQ AMBULATORY SITE LICENSE (M70208-UP) ENDOPRO IQ CAPTURE LICENSE (M70206) DOC-U-SCRIBE REPORTING (M70213) ENDOPORTAL UPGRADE (9265) HD SDI IMAGE CAPTURE PC (KBM68404) VIDEO VIEWER FOR KAYPENTAX DIGITAL VIDEO (9221) PATHOLOGY SYSTEM INTERFACE (M70224) ENDOPORTAL WORKSTATION LICENSE (9252-1) ATEN VS162,2 PORT DVI VIDEO SPLITTERS (90138) HL7 INTERFACE INBOUND (9267) NURSING NOTES (M70214-UP) MS SQL STD - 8 CORE LICENSE (MSSQL-S8) DICOM INTERFACE FOR SWALLOWING (7251) ENDOPRO IQ REVIEW LICENSE, 1-4 (M70216-UP) COMPUTER ACCESSORIES (68403-ACC) VITALS MONITOR INTERFACE (M70223-UP) HD DVI IMAGE CAPTURE PC (KBM68403) ENDOPRO IQ CAPTURE LICENSE (M70206-UP) VITALS MONITOR INTERFACE (M70223) HL7 INBOUND INTERFACE, ADT/SIU/ORM (M70220) ENDOPRO IQ, PER OR ROOM (M70210) ENDOPRO IQ HOSPITAL SITE LICENSE (M70207-UP) IQ ADVANCED ANALYTICS, 5 TOKENS (M70235) ENDOPRO CAPTURE WORKSTATION (KBM68346) MATROX VIO CAPTURE CARD (M30119) MIC PRE-AMP KIT, ROLLS MP-13 (7190-5300) EXTRON 4 CHANNEL VGA VIDEO SWITCH (68404) FILE SERVER DELUXE RACK MOUNTABLE (68394) ENDOPRO IQ CITRIX/VIRTUALIZATION LICENSE (M70204-UP) PATHOLOGY SYSTEM INTERFACE (M70224-UP) MATROX ORION HD CAPTURE CARD (M30126) MICROSOFT SQL RUNTIME (M70227) HL7 OUTBOUND INTERFACE, ORU (M70221) ENDOPRO IQ, PER OR ROOM (M70210-UP) STANDALONE IMAGE CAPTURE PC (KBM68407) HD - DIGITAL VIDEO CAPTURE (9310HD) ENDOSERVER WORKSTATION LICENSE (9282-3) UNIVERSAL POWER SUPPLY WITH BACKUP (68262) ENDOPRO IQ REVIEW LICENSE, UNLIMITED (M70219-UP) ENDOPRO IQ HOSPITAL SITE LICENSE (M70207) ENDOREMOTE (M70211) ENDOPRO IQ REVIEW LICENSE, 10-19 (M70217-UP) FOOT SWITCH, USB-FS81-SP-USB (1111-1978) ENDOPRO IQ REVIEW LICENSE, UNLIMITED (M70219) ENDOPRO IQ REVIEW LICENSE, 20-30 (M70218-UP) HL7 OUTBOUND INTERFACE UNC/PDF ADD-ON (M70222) HL7 OUTBOUND INTERFACE, ORU (M70221-UP) ENDOPRO IQ, PER MOBILE CART (M70209) IQ ANALYTICS 5 USER LICENSE PACK (M70229) ENDOPRO IQ REVIEW LICENSE, 5-9 (M70205) ENDOPORTAL (9263) DIGITAL CAPTURE (9372HD) DIGITAL VIDEO CAPTURE MODULE (9200D) HL7 INBOUND INTERFACE, ADT/SIU/ORM (M70220-UP) DVD-RW DRIVE, EXTERNAL USB (1111-1977) COMPUTER ACCESSORIES (68391-ACC) ENDOPRO IQ, PER MOBILE CART (M70209-UP) CAPSOACCESS (CAPSO2668) ASSY: ECAP NTSC 6 CHANNEL (KBM68306) ENDOPRO IQ REVIEW LICENSE, 10-19 (M70217) USB SWITCH INTERFACE (9173B) MEDICAL GRADE FOOTSWITCH (90139) MPS VIDEO CAPTURE (M70212) ENDOPRO IQ AMBULATORY SITE LICENSE (M70208) ASSY: SERVER, TOWER FORM FACTOR (KBM68311) HL7 INTERFACE OUTBOUND (9269) Pathology Orders Interface (M70236) Complete HL7 Interface Package Split (M70245-SPLIT) Scope Management (M70244) Billing Module (M70243) Pathology Module (M70238) Pathology Reports Interface (M70237) Complete HL7 Interface Package (M70245) CapsoConnect (M70241) endoPRO 2020 Pentax connect for Capulse (M70240) DICOM Module (M70242) endoSHEET (M70248) Pathology Module Complete (M70239) DIGITAL CAPTURE (9380)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198