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Guideline 4000™ Resident Expert Software Module, 1x
FHC, INC.
C0258-00808
Not in Commercial Distribution
- 00873263008089 ()
C0258
- Neurological stereotactic surgery system
Standard Imaging StructSure Software is designed to be used to assess the anatomical capabilities of: 1) clinical professionals who are responsible for contouring organs-at-risk and target volumes, i.e. manual contouring; and 2) automated contouring software systems, i.e. auto-segmentation.
STANDARD IMAGING INC.
91340
In Commercial Distribution
- 00866562000281 ()
91340
- Accelerator system quality assurance device
Standard Imaging RAy Software is a film dosimetry application, designed to perform one-dimensional, two-dimensional, and three-dimensional analyses of dose deposition pattern on film under specific mega-voltage irradiation setups.
STANDARD IMAGING INC.
91336
In Commercial Distribution
- 00866562000274 ()
91336
- Radiation therapy software
Standard Imaging LinacView Software is a stand alone software medical device used for logfile analysis of radiation therapy systems.
STANDARD IMAGING INC.
91330
In Commercial Distribution
- 00866562000267 ()
91330
- Radiation therapy software
Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems.
STANDARD IMAGING INC.
v5
In Commercial Distribution
- 00866562000236 ()
91309
- Radiation therapy software
E-LINK is a computerized modular system bringing both evaluation and exercise together in an exciting format with an extensive scope of clinical applications for the upper and lower extremities.
E-LINK is available in English, Chinese, German and Spanish.
BIOMETRICS LIMITED
16xx-xxx-xxxx
In Commercial Distribution
- 05060481690454 ()
- Biomechanical function analysis/rehabilitation software
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
SW-1
In Commercial Distribution
- 00843152104000 ()
SW-1
- Electromagnetic surgical navigation device tracking system
No Description
Cochlear Bone Anchored Solutions AB
V 7.0
In Commercial Distribution
- 09321502075510 ()
P2121898
- Hearing aid wireless-fitting computer-aided set
AVATAR MEDICAL Software V1 is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. AVATAR MEDICAL Software V1 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
AVATAR MEDICAL
AMS V1
Not in Commercial Distribution
- 03770026095003 ()
- Radiology picture archiving and communication system workstation
No Description
ACCUTOME, INC.
4.07.02-U
In Commercial Distribution
- 00897826002178 ()
- Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
4.07.02-U
In Commercial Distribution
- 00897826002161 ()
- Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
1.03.03-U
In Commercial Distribution
- 00897826002154 ()
- Ophthalmic ultrasound imaging system
The THD Procto Software System is a diagnostic system intended to be used to investigatepelvic floor disorders, and specifically the THD Procto Software together with its accessories and devices (endoanal probe, video camera and THD Anopress), is able to be applied for:
- Endoanal ultrasound (trans-rectal ultrasound / echography)
- Anoscopy exams
- Manometry exams
THD SPA
THD Procto Software
In Commercial Distribution
- 08033737713037 ()
760004
- Ultrasound imaging system application software
Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version.
EB NEURO SPA
B8640053000
In Commercial Distribution
- 08056446900642 ()
- Bioelectrical signal analysis software
No Description
HELENA LABORATORIES CORPORATION
1691000
In Commercial Distribution
- M52516910000 ()
- Densitometry analyser IVD
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
271627
In Commercial Distribution
- 03661489716270 ()
- Orthopaedic/craniofacial implantation planning software
No Description
NXSTAGE MEDICAL, INC.
NX1000-16-F
In Commercial Distribution
- M535NX100016F0 ()
- Haemodialysis system, institutional/home-use
No Description
NXSTAGE MEDICAL, INC.
NX1000-10-G
In Commercial Distribution
- M535NX100010G0 ()
- Haemodialysis system, institutional/home-use
No Description
NXSTAGE MEDICAL, INC.
NX1000-10-F
In Commercial Distribution
- M535NX100010F0 ()
- Haemodialysis system, institutional/home-use
No Description
NXSTAGE MEDICAL, INC.
NX1000-10-E
In Commercial Distribution
- M535NX100010E0 ()
- Haemodialysis system, institutional/home-use