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510(k) Data Aggregation
K Number
K073310Device Name
OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL
Manufacturer
HITACHI MEDICAL CORP.
Date Cleared
2008-01-18
(56 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The OASIS Specialty Coils are receive-only devices that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved crosssectional images that display the internal structure of the images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
The indications for use for the OASIS Specialty Coils are as follows:
- The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used . for MRI imaging of the human cervical spine, and thoracic spine.
- . The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only multiple array device used for MRI imaging of the abdomen.
- The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple . array device used for MRI imaging of the abdomen.
- The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array . device used for MRI imaging of the foot.
Device Description
The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used for obtaining diagnostic images of the human cervical spine, and thoracic spine with the OASIS MRI System.
The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only multiple array device used for obtaining diagnostic images of the abdomen with the OASIS MRI System.
The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple array device used for obtaining diagnostic images of the abdomen with the OASIS MRI System.
The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array device used for obtaining diagnostic images of the foot with the OASIS MRI System.
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K Number
K061608Device Name
MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
Manufacturer
HITACHI MEDICAL CORP.
Date Cleared
2006-11-22
(166 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: General (Track I only), Specific (Tracks I & III) including Ophthalmic, Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Intra-luminal, Other (spec.), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Other (spec.), Peripheral vessel, Other (spec.).
Device Description
The Hitachi EUB-5500 Diagnostic Ultrasound Scanner is a Track 3 Diagnostic Ultrasound Pulsed Doppler and Pulsed Echo Imaging System capable of the following operating functions: B Mode, M Mode, Pulsed Doppler Color Flow, Continuous Wave Doppler, Amplitude Doppler, Harmonic imaging, Superficial musculoskeletal imaging, 3D imaging, 4D imaging.
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K Number
K053258Device Name
EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
Manufacturer
HITACHI MEDICAL CORP.
Date Cleared
2005-12-09
(17 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Device Description
EUB-6500 Diagnostic Ultrasound Scanner
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K Number
K042501Device Name
ETG-4000 OPTICAL TOPOGRAPHY SYSTEM
Manufacturer
HITACHI MEDICAL CORP.
Date Cleared
2004-10-12
(28 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the ETG-4000 is the measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin.
Device Description
The ETG-4000 is a device that measures relative changes in tissue concentration of oxy-hemoglobin and deoxy-hemoglobin and total hemoglobin (678-1200 m) that sam near-infrared light (670-1300nm) that can the surface area of the cerebra. Sed is absorbed by the hemoglobin in the blood.
The ETG-4000 displays the changes of overall Hemoglobin concentration in time- course images (motion images and still images) based on the data from multiple point measurements.
This is a non-invasive test that is done by contacting an array of small optical fiber tips on the surface of the scalp.
The ETG-4000 beams frequency modulated near-infrared light into the surface of the brain. The light passes through the scalp, skull and upper layer of illiough several or the optical noves read by the hemoglobin in the blood and is reflected back and is collected by optical fibers.
The ETG-4000 measures relative changes in tissue concentration of oxy-hemoglobin and deoxy-hemoglobin at multiple points on the head simultaneously by utilizing the changes of light absorption.
The ETG-4000 provides data that show the activity status of the cerebral cortex by displaying the changes of oxy-hemoglobin and deoxy-hemoglobin concentration in the brain surface, and the metabolic and circulatory status of the cerebral cortex in a time-course graphic representation of oxy-hemoglobin, deoxy-hemoglobin and total hemoglobin, 2D dynamic images and 3D dynamic images.
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K Number
K013722Device Name
MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER
Manufacturer
HITACHI MEDICAL CORP.
Date Cleared
2002-02-11
(94 days)
Product Code
IYN
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic Imaging and 3D Imaging.
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of transvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy.
Device Description
The Imagin 2011 0000 Diagnoons aging system capable of the following operating pulsed Doppler und palsed continuous Wave Doppler, Color Flow (including Amplitude Doppler). It is also intended for harmonic imaging, superficial musculoskeletal imaging, and 3D imaging.
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K Number
K013723Device Name
MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
Manufacturer
HITACHI MEDICAL CORP.
Date Cleared
2002-02-06
(89 days)
Product Code
ITX
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
General (Track I only), Specific (Tracks I & III)
Mode of Operation: B, M, Pulsed Doppler, Continuous Wave Doppler, Color Doppler, Combined (Spec.), Other (Spec.)
Other (Spec.) includes Amplitude Doppler, Harmonic Imaging and 3D Imaging.
Specific clinical applications vary by transducer.
Device Description
The Hitachi EUB-6500 Diagnostic Ultrasound Scanner is a Track 3 diagnostic ultrasound pulsed Doppler and pulsed echo imaging system capable of the following operating modes: B, M, Pulsed Doppler, Continuous Wave Doppler, Color Flow (including Amplitude Doppler). It is also intended for harmonic imaging, superficial musculoskeletal imaging, and 3D imaging.
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K Number
K012239Device Name
MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM
Manufacturer
HITACHI MEDICAL CORP.
Date Cleared
2001-08-10
(24 days)
Product Code
IYN
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: endoscopic observation of the gastrointestinal tract (esophagus, stomach, duodenum, large intestine) and biliary system (pancreato-biliary ducts).
Device Description
The subject device consists of:
- EUB-525/EUB-2000 Diagnostic Ultrasound Scanner
- SP-711UA Ultrasonic Probe Connecting Unit
- TL-1A Translator
- Probe (PL Series or PL26-7.5 Series)
- Balloon and Sheath
The Hitachi EUB-525/EUB-2000 operating controls and their associated functions do not change with the addition of the Fujinon SP-711 Sonoprobe system. The operating controls specific to the Fujinon SP-711 system are described in the operation manuals included with this document in Section 7.
The transducers subject to this submission are the same transducers described in the previously cleared 510(k) K011252. They are: PL1726-20, PL1726-15, PL1726-12, PL1726-7.5, PL1926-20, PL1926-15, PL1926-12, PL1926-7.5, PL2226-20, PL2226-15, PL2226-12, PL2220-20, PL2220-15, PL2220-12, PL2220-7.5.
The PL26-7.5 probe series includes one type for use with a balloon/sheath and the other type for use without a balloon. The only difference between probes is the structure of the tip. The probes made for use with a balloon/sheath have a groove on the tip to catch the balloon head. The probes made for use without a balloon are slightly shorter. The choice of the probe type is at the discretion of the physician. Since ultrasound waves are stronger in water, the physician may choose to use the balloon version to improve image quality. The probes made for use with a balloon/sheath are designated with a "B" (i.e. PL26B-7.5) and must be used with a balloon adapter, balloon sheath, and balloon as described in the operation manual.
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K Number
K011252Device Name
EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM
Manufacturer
HITACHI MEDICAL CORP.
Date Cleared
2001-05-30
(36 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994026Device Name
EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER
Manufacturer
HITACHI MEDICAL CORP. OF AMERICA
Date Cleared
2000-03-29
(124 days)
Product Code
IYN
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL CORP. OF AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
General (Track I only)
Specific (Tracks I & III)
Ophthalmic
Fetal
Abdominal
Intra-operative (Spec.)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (Spec.)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)
Device Description
The Hitachi EUB-6000 Ultrasound Diagnostic Scanner is a Track 3 diagnostic ultrasound pulsed Doppler and pulsed echo imaging system capable of the following operating modes: B (including harmonic imaging), M, Pulsed and Continuous Doppler, and Color Flow (including Amplitude Doppler). It is intended for general ultrasound imaging of the human body, with specific uses under the general applications of cardiac, peripheral vessel, and fetal imaging and other.
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K Number
K991535Device Name
CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
Manufacturer
HITACHI MEDICAL CORP. OF AMERICA
Date Cleared
1999-07-30
(88 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL CORP. OF AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended uses of Convergence™ CDR®M for Hitachi SPECTRADigital™V250DSP Gameras is identical to the principle of coincidence imaging used by EPIC-MCD Cleared under K952684, ADAC MCD-AC cleared under K971980 in intended use, methods, reconstruction algorithms, transmission source type, and effectiveness of application. These include:
- Acquisition of patient specific biodistribution of positron-emitting radioisotopes in-vivo.
- Acquisition of patient specific anatomic density via transmission imaging to determine attenuation coefficients applicable to emission slice data.
- Reformation of coincidence data to images frames with subsequent reconstruction of transmission and Wholebody ECT data via FBP and/or ML-EM/OSEM reconstruction methods.
- Analysis and generation of attenuation maps and coefficients to apply to emission ECT slice/volume sets.
Convergence sm for for Hitachi with Imaging capabilities SPECTRADigital™ V250DSP Gamma Cameras option include:
- All SPECT procedures in common practice including matrix based spatial framed, temporal/spatial list mode and angular projection mode static, gated and multi-orbit sampling
- Use in conjunction with FDA approved 511 keV emitting radiopharmaceuticals
- High and normal count-rate dynamic and non-temporal ECT
- In conjunction with Coincidence based imaging, the detector performance and NUA® acquisition and processing characteristics are available for non-uniform attenuation ECT, attenuation correction in CID and CID based ECT imaging.
- Multiple window sampled imaging, including scatter correction via single, dual or plural window processing.
Device Description
CONVERGENCE®M CDR §™ for Hitachi SPECTRADigital™ V250DSP Gamma Cameras, cleared under K954129 is an Coincidence Imaging Device (CID) option that provides capability to acquire 511 keV coincidence events and form images in 1D, 2D and 3D modes of operation. With the addition of ATTCOR, non-linear scaled low energy transmission correction utilizing NUA88 submitted under K991318) mapping of anatomical information using external radioactive line source transmission with analysis of densities and assignment of patient specific attenuation coefficients to minimize distortion due to overlying tissue and undesired scattered photons. The device is a combination of hardware and software to provide detection, decoding, image formation with corrections and Whole body and tomographic reconstruction. When the system is equipped with thicker 5/8" crystals submitted under K991129, the V250DSP efficiency for 511 keV events is improved.
The additional Hardware which consists of Aperture Grids with graded absorbers, high speed pre-amps with coincident signal timing, high speed decoding and correction circuitry and acquisition control software. 1-D framing at the camera system is provided and 2-D, 3-D frame formation via workstation based FORE (Fourier Rebinning) and OS-EM processes. When equipped with ATTCORSM, a single, non-moving line source holder equipped with shutter, special line source slat collimation to minimize patient exposure and axial scatter and non-linear scaling processing is provided. The software consists of FORE rebinning. OSEM iterative and/or FBP (Filtered Back-Projection) reconstruction, transmission acquisition control and coefficient determination in the correction to ECT slice data per NUASM submitted under K991318.
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