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Monarch™ Software Laptop v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution
- B634SW0032760201050 ()
- CT system application software
Monarch™ Software Laptop v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution
- B634SW0032760201040 ()
- CT system application software
Monarch™ Software Laptop v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution
- B634SW0032760201030 ()
- CT system application software
Monarch™ Software Cart v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution
- B634SW0032750201050 ()
- Robotic surgical system application software
Monarch™ Software Cart v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution
- B634SW0032750201040 ()
- Robotic surgical system application software
Monarch™ Software Cart v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution
- B634SW0032750201030 ()
- Robotic surgical system application software
Monarch™ Software Tower v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution
- B634SW0032740201050 ()
- Robotic surgical system application software
Monarch™ Software Tower v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution
- B634SW0032740201040 ()
- Robotic surgical system application software
Monarch™ Software Tower v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution
- B634SW0032740201030 ()
- Robotic surgical system application software
Window Field Generator, Connection Cable, Mounting System
AURIS HEALTH, INC.
MON-000709
In Commercial Distribution
- B634MON0007091 ()
- B634MON0007090 ()
MON-000709
- Robotic surgical arm system
The Monarch Platform (Refurbished) enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
AURIS HEALTH, INC.
MON000005R
In Commercial Distribution
- B634MON000005R0 ()
MON000005R
- Robotic surgical arm system
Monarch Endoscopy Platform (P1) Tower Upgrade
AURIS HEALTH, INC.
MON-000005-01
In Commercial Distribution
- B634MON000005010 ()
- Robotic surgical arm system
The Monarch Platform enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
AURIS HEALTH, INC.
MON000005
In Commercial Distribution
- B634MON0000050 ()
MON000005
- Robotic surgical arm system
Upgrade to Certus 140-2.45GHz Ablation Confirmation
NEUWAVE MEDICAL, INC.
AC-UPGRADE
Not in Commercial Distribution
- 00818913020257 ()
AC-UPGRADE
- Microwave ablation system generator
SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head including
the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ),
other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use in
diagnostic support. The device displays two and three dimensional images for each examined anatomical region.
The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
Epica Medical Innovations LLC
9801101000
Not in Commercial Distribution
- 86000594161101 ()
86000594161101
- Cone beam computed tomography system, head/neck
The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOHM
In Commercial Distribution
- B201CGOHM0 ()
- B201CGOHM1 ()
CG-OH-M
- Radiological video camera patient positioning/tracking system camera
- Optical surgical navigation device tracking system
0.35mm x 2.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle.
Izi Medical Products, LLC
SHZ-035-020-22
In Commercial Distribution
- SHZ03502022 ()
SHZ-035-020-22
- Radiological image marker, implantable
0.35mm x 1.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle.
Izi Medical Products, LLC
SHZ-035-010-22
In Commercial Distribution
- SHZ03501022 ()
SHZ-035-010-22
- Radiological image marker, implantable
0.35mm x 0.5cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle.
Izi Medical Products, LLC
SHZ-035-005-22
In Commercial Distribution
- SHZ03500522 ()
SHZ-035-005-22
- Radiological image marker, implantable
This device is used to acquire transaxial images of any desired region of the body, providing a wide range of diagnostic capabilities.
CANON MEDICAL SYSTEMS CORPORATION
PCD-1000A
In Commercial Distribution
- 04987670103810 ()
- PET/CT system
No Description
Siemens Healthcare GmbH
11665780
In Commercial Distribution
- 04056869996172 ()
- CT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
Bigraph Vision Quadra
In Commercial Distribution
- 04056869269429 ()
- PET/CT system
No Description
Brainlab AG
4.0
In Commercial Distribution
- 04056481143015 ()
- Stereotactic system application software
No Description
Brainlab AG
2.0
In Commercial Distribution
- 04056481142186 ()
- Radiological PACS software
- Stereotactic system application software
No Description
Brainlab AG
4.0
In Commercial Distribution
- 04056481140816 ()
- Radiological PACS software
- Stereotactic system application software
No Description
Brainlab AG
1.1
Not in Commercial Distribution
- 04056481140571 ()
21735-02B
- Radiological PACS software
No Description
Brainlab AG
1.0
In Commercial Distribution
- 04056481138530 ()
- Radiological PACS software
- Stereotactic system application software
No Description
Brainlab AG
3
Not in Commercial Distribution
- 04056481108755 ()
- Robotic surgical navigation system
No Description
Siemens Healthcare GmbH
11665409
Not in Commercial Distribution
- 04056869964331 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11583323
In Commercial Distribution
- 04056869297279 ()
- CT system application software
OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY - WSO
GE MEDICAL SYSTEMS, INC.
Legend
In Commercial Distribution
- 00195278901439 ()
- Full-body CT system
- PET system
AURORA NM GANTRY FINAL
G E MEDICAL SYSTEMS ISRAEL LTD.
SPECT with Revolution Ascend CT
In Commercial Distribution
- 00195278878502 ()
- Full-body CT system
- Stationary gamma camera system
StarGuide SW and Labels Upgrade
G E MEDICAL SYSTEMS ISRAEL LTD.
5962426
In Commercial Distribution
- 00195278870490 ()
5962426
- Stationary gamma camera system
- Full-body CT system
SnapShot Freeze Medical Device
GE MEDICAL SYSTEMS, INC.
1.1
In Commercial Distribution
- 00195278865335 ()
5963072
- CT system application software
Spectral Bone Marrow MD Application Container for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution
- 00195278630377 ()
5929650
- CT system application software
Spine Auto Views Medical Device
GE MEDICAL SYSTEMS
See CODE part
In Commercial Distribution
- 00195278534064 ()
- CT system application software
OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY
GE MEDICAL SYSTEMS, INC.
Legend
In Commercial Distribution
- 00195278454218 ()
- Full-body CT system
- PET system
STARGATE NM GANTRY FINAL
G E MEDICAL SYSTEMS ISRAEL LTD.
H3911AB
In Commercial Distribution
- 00195278118295 ()
- Stationary gamma camera system
- Full-body CT system
PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manufacturing Make
GE MEDICAL SYSTEMS, INC.
MI
In Commercial Distribution
- 00195278098603 ()
- Full-body CT system
- PET system
D630 to D670 DR NM GANTRY UPGRADE KIT
G E MEDICAL SYSTEMS ISRAEL LTD.
H3101RS
In Commercial Distribution
- 00195278794772 ()
5953035
- Stationary gamma camera system
- Full-body CT system