SEARCH RESULTS FOR: (*Boise State University本科成绩单<网址:ｚｊｗ２１１.ｃｏｍ>白银Natsional*)(4472 results)

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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ArtPIX DRF - 07290012104909

No Description
C.M.T. MEDICAL TECHNOLOGIES LTD.
63627589
In Commercial Distribution

  • 07290012104909 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital

Radmedix AcuityDR 1013 G4 - 00810035220515

AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220515 ()


  • Indirect flat panel x-ray detector

Radmedix AcuityDR 1417 G4 - 00810035220508

AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220508 ()


  • Indirect flat panel x-ray detector

Radmedix AcuityDR 1717 G4 - 00810035220492

AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220492 ()


  • Indirect flat panel x-ray detector

Varex Digital Imaging Software, Nexus, DRF, v3.7 - 00854344007634

No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.7
In Commercial Distribution

  • 00854344007634 ()


  • X-ray system computer, diagnostic, general-purpose

Varex Digital Imaging System, Nexus, RF/DR, Digital Receptor - 00854344007054

No Description
VAREX IMAGING CORPORATION
Nexus-DRF
In Commercial Distribution

  • 00854344007054 ()


  • X-ray system computer, diagnostic, general-purpose

100NX DUO Upgrade Kit with VELOCITY - 10705037068173

100NX DUO Upgrade Kit with VELOCITY
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
10137V
In Commercial Distribution

  • 10705037068173 ()
10137V

  • Plasma sterilizer
  • Instrument tray, reusable

Intra Oral Sensor - 08809460309867

Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays.
Dentium Co., Ltd
IOX2
In Commercial Distribution

  • 08809460309867 ()
IOX2

  • Dental digital imaging sensor, intraoral

Intra Oral Sensor - 08809460309850

Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays.
Dentium Co., Ltd
IOX1
In Commercial Distribution

  • 08809460309850 ()
IOX1

  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D764B13162000

FONA STELLARIS S0 SENSOR
SIRONA DENTAL, INC.
B1316200
In Commercial Distribution

  • D764B13162000 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D764B12162000

FONA STELLARIS S2 SENSOR
SIRONA DENTAL, INC.
B1216200
In Commercial Distribution

  • D764B12162000 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D764B11162000

FONA STELLARIS S1 SENSOR
SIRONA DENTAL, INC.
B1116200
In Commercial Distribution

  • D764B11162000 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000055751

FONA STELLARIS S0 SENSOR BASIC KIT, .9M/3FT
SIRONA DENTAL, INC.
100005575
In Commercial Distribution

  • D7641000055751 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000055741

FONA STELLARIS S0 SENSOR BASIC KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005574
In Commercial Distribution

  • D7641000055741 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000055731

FONA STELLARIS S1 SENSOR BASIC KIT, .9M/3FT
SIRONA DENTAL, INC.
100005573
In Commercial Distribution

  • D7641000055731 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000055721

FONA STELLARIS S1 SENSOR BASIC KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005572
In Commercial Distribution

  • D7641000055721 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000055711

FONA STELLARIS S2 SENSOR BASIC KIT, .9M/3FT
SIRONA DENTAL, INC.
100005571
In Commercial Distribution

  • D7641000055711 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000055701

FONA STELLARIS S2 SENSOR BASIC KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005570
In Commercial Distribution

  • D7641000055701 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000055671

FONA STELLARIS S0 SENSOR BASIC KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005567
In Commercial Distribution

  • D7641000055671 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000055661

FONA STELLARIS S1 SENSOR BASIC KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005566
In Commercial Distribution

  • D7641000055661 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000055651

FONA STELLARIS S2 SENSOR BASIC KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005565
In Commercial Distribution

  • D7641000055651 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000054201

FONA STELLARIS S0 SENSOR SHIP KIT, .9M/3FT
SIRONA DENTAL, INC.
100005420
In Commercial Distribution

  • D7641000054201 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000054191

FONA STELLARIS S0 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005419
In Commercial Distribution

  • D7641000054191 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000054181

FONA STELLARIS S0 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005418
In Commercial Distribution

  • D7641000054181 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000054121

FONA STELLARIS S1 SENSOR SHIP KIT, .9M/3FT
SIRONA DENTAL, INC.
100005412
In Commercial Distribution

  • D7641000054121 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000054111

FONA STELLARIS S1 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005411
In Commercial Distribution

  • D7641000054111 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000054101

FONA STELLARIS S1 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005410
In Commercial Distribution

  • D7641000054101 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000053931

FONA STELLARIS S2 SENSOR SHIP KIT, .9M/3FT
SIRONA DENTAL, INC.
100005393
In Commercial Distribution

  • D7641000053931 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000053921

FONA STELLARIS S2 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005392
In Commercial Distribution

  • D7641000053921 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000053911

FONA STELLARIS S2 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005391
In Commercial Distribution

  • D7641000053911 ()


  • Dental digital imaging sensor, intraoral

OrthoScan Pulse Mini C-arm - B22510000004FD0

Image-intensified fluoroscopic x-ray system, mobile
Ziehm-Orthoscan, Inc.
1000-0004-FD
In Commercial Distribution

  • B22510000004FD0 ()


  • Portable general-purpose fluoroscopic x-ray system, digital

Lock Activator - 10855068008423

Reusable surgical instrument used during pelvic fixation procedure to convert a flexible intramedullary implant to a rigid state in order to stabilize and repair a bone fracture.
Curvafix Inc
CLA-001
In Commercial Distribution

  • 10855068008423 ()
CLA-001

  • Surgical screwdriver, reusable

Lock Activator - 10855068008409

Reusable surgical instrument used during pelvic fixation procedure to convert a flexible intramedullary implant to a rigid state in order to stabilize and repair a bone fracture.
Curvafix Inc
CSA-001
In Commercial Distribution

  • 10855068008409 ()
CSA-001

  • Surgical screwdriver, reusable

Power Dental USA - D943P29090

PLASTIC FILLING W3 PFIW3
Power Dental U.S.A. Inc.
P2909
In Commercial Distribution

  • D943P29090 ()
P2909

  • Margin finishing dental file/rasp, reusable
  • Dental spatula, reusable
  • Dental material application tool, single-use

CR-IR 392 - 04547410472905

The CR-IR 392 is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410472905 ()


  • Computed radiography digital imaging scanner

CR-IR 392 - 04547410472882

The CR-IR 392 is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410472882 ()


  • Computed radiography digital imaging scanner

CR-IR 392 - 04547410343816

The CR-IR 392 is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410343816 ()


  • Computed radiography digital imaging scanner

Definium - 00195278118356

Definium Tempo System UDI
GE Hualun Medical Systems Co., Ltd
Tempo
In Commercial Distribution

  • 00195278118356 ()
B2401CAB

  • Stationary basic diagnostic x-ray system, digital

Definium - 00195278070265

Definium Tempo Pro System UDI
GE Hualun Medical Systems Co., Ltd
Tempo Pro
In Commercial Distribution

  • 00195278070265 ()
B2402CAB

  • Stationary basic diagnostic x-ray system, digital

Discovery - 00840682115322

XR656 SYS Cabinet UDI
GE Hualun Medical Systems Co., Ltd
XR656
In Commercial Distribution

  • 00840682115322 ()


  • Stationary basic diagnostic x-ray system, digital

Discovery - 00840682138598

Discovery XR656 HD System
GE Hualun Medical Systems Co., Ltd
XR656 HD
In Commercial Distribution

  • 00840682138598 ()


  • Stationary basic diagnostic x-ray system, digital

SIUI - 06938396423025

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300S
In Commercial Distribution

  • 06938396423025 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396423018

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300
In Commercial Distribution

  • 06938396423018 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396410063

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1000S
In Commercial Distribution

  • 06938396410063 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396410049

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1000
In Commercial Distribution

  • 06938396410049 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400767

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300T
In Commercial Distribution

  • 06938396400767 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400446

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2100S
In Commercial Distribution

  • 06938396400446 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400439

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2100
In Commercial Distribution

  • 06938396400439 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400422

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1100S
In Commercial Distribution

  • 06938396400422 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400415

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1100
In Commercial Distribution

  • 06938396400415 ()


  • Portable basic diagnostic x-ray system, digital
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