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510(k) Data Aggregation
K Number
K120305Device Name
THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV
Manufacturer
THINKING SYSTEMS CORP.
Date Cleared
2012-07-09
(159 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
THINKING SYSTEMS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ThinkingNet is a Medical Image Management and Review System, commonly known as PACS. ThinkingNet made by Thinking Systems Corporation, Florida, USA, is indicated for acceptance, transmission, storage, archival, reading, interpretation, clinical review, analysis, annotation, distribution, printing, editing and processing of digital images and data acquired from DICOM compatible diagnostic device, by healthcare professionals, including radiologists, cardiologists, physicians, technologists and clinicians.
- With a ThinkingWeb option it can be used to access diagnostic information remotely with all workstation functionality or to collaborate with other users. The client device is cross platform for all but the thick-client ThinkingNet.Net option.
- With the molecular imaging option it can be used for processing and interpreting nuclear medicine and other molecular imaging studies.
- With image co-registration and fusion option it can be used for processing and interpreting PET-CT, PET-MRI, SPECT-CT and other hybrid imaging studies.
- With the Mammography option it can be used for screening and diagnosis (with -MG, "For presentation" images only) from FDA approved modalities in softcopy (using FDA cleared displays for mammography) and printed formats.
- With the cardiology option it can be used for reading, interpreting and reporting cardiac studies, such as nuclear cardiac, PET cardiac, echocardiographic, X-ray angiographic and CTA studies.
- With the Orthopedic option it can be used to perform common orthopedic measurements of the hip, knee, spine, etc.
OR
- With the 3D/MPR option it can be used to volumetric image data visualization: -MIP, MPR, VR and triangulation.
- With the Quality Assurance option it can be used by PACS administrators or clinicians to perform quality control activities related to patient and images data.
Device Description
ThinkingNet is a multi-modality PACS/RIS with applications optimized for each individual imaging modality. The image data and applications can be accessed locally or remotely. ThinkingNet workstation software is designed as diagnostic reading and processing software packages, which may be marketed as software only, as well as packaged with standard off-the-shelf computer hardware.
The base functions include receiving, transmission, storage, archival, display images from all imaging modalities. When enabled, the system allows remote access of image data and applications over a local or wide area network, using a Web browser, thick-client, thin-client or cloud-based remote application deployment method.
Options allow for additional capability, including modality specific applications, quantitative postprocessing, modality specific measurements, multi-planar reformatting and 3D visualization.
ThinkingNet Molecular Imaging modules offer the image processing functionality, through MDStation and ThinkingWeb, that have the same indication as the predicate modality workstations. It delivers image processing and review tools for applications used in functional imaging modalities, such as nuclear medicine, PET, PET/CT, SPECT/CT and PET/MRI.
ThinkingNet Mammo module is a diagnostic softcopy breast imaging workstation with diagnostic print capability.
- It displays and prints regionally approved DICOM DR Digital Mammography Images (MG . SOP class) with a default or user defined mammography hanging protocol.
- . It displays and prints regionally approved DICOM CR Digital Mammography Images (CR SOP class) a default or user defined mammography hanging protocol.
- It displays adjunct breast imaging modality studies (i.e. Breast MR, Breast . PET and Breast gamma camera) for comparison.
ThinkingWeb modules offer comprehensive remote image and application access methods to allow clinicians to review and process images remotely. It has the following modules.
- . ThinkingWebLite: Clientless image distribution via simple Web browser (see NuWEB in K010271). It is primarily a referral physician's portal, not intended for primary reading.
- . ThinkingNet.Net: A thick-client implementation using an existing image review module (NuFILM) with a proprietary image streaming mechanism.
- . ThinkingWeb: Cross-platform thin-client remote application access based the existing MDStation software and off-the-shelf remote computing technology.
- . ThinkingWeb Extreme: A cloud-based remote application deployment implementation based the existing MDStation software and off-the-shelf cloud computing technologies.
Besides ThinkingNet.Net, all ThinkingWeb products support cross-platform client computer devices. Thinking Net uses Windows-based client computer.
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K Number
K033189Device Name
KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
Manufacturer
KING SYSTEMS CORP.
Date Cleared
2004-05-04
(216 days)
Product Code
CAE
Regulation Number
868.5110Why did this record match?
Applicant Name (Manufacturer) :
KING SYSTEMS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KING LTS is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration oonlour vehilation is considered to have a low risk of aspiration of stomach contents.
Device Description
Tube with two attached, inflatable balloons. Ventilation openings between the balloons. Can be sterilized in an autoclave. Proximal ISO Standard 15mm connector for attachment to breathing circuit. Medical grade polymers or approved materials for all components in contact with the anesthesia gas stream. Connected to a Breathing Circuit. Inserted blindly. Seals the esophagus. Cuffs are inflated with one inflation port. Instructions that patient should have fasted before using the product. Latex free product.
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K Number
K033186Device Name
KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
Manufacturer
KING SYSTEMS CORP.
Date Cleared
2004-04-14
(196 days)
Product Code
CAE
Regulation Number
868.5110Why did this record match?
Applicant Name (Manufacturer) :
KING SYSTEMS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KING LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Device Description
Each device is constructed of medical grade elastomeric and thermoplastic materials. All fittings conform to ISO 5356-1/1996: Anesthetic and Respiratory Equipment - Conical Connectors; Part 1 Cones and Sockets. The device incorporates the following components or features:
- . Bi-directional gas flow through a ventilation channel.
- Inflatable bladders to assist in maintenance of placement and in sealing the . airway from the stomach and from the atmosphere
- . Indicators for proper placement permanently printed on the tube
- A rigid plastic connector complying with ISO standards for the 15mm connection . to the patient end of a breathing circuit.
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K Number
K021634Device Name
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
Manufacturer
KING SYSTEMS CORP.
Date Cleared
2003-01-09
(237 days)
Product Code
CAE
Regulation Number
868.5110Why did this record match?
Applicant Name (Manufacturer) :
KING SYSTEMS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KING LT oropharyngeal airway is intended for use in adult patients for controlled ventilation during anesthesia for procedures of short duration, when the patient is considered to have a low risk of aspiration of stomach contents.
Device Description
Not Found
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K Number
K012485Device Name
MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE
Manufacturer
KING SYSTEMS CORP.
Date Cleared
2001-10-09
(68 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
KING SYSTEMS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- A breathing circuit bacterial filter is a device that is intended to remove 1. microbiological and particulate matter from the gases of a breathing circuit.
- A heat and moisture exchanger (HME) is a device intended to be 2. positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by a patient during anesthesia or ventilator care.
- ventifator care.
Each All-Round® filter or HME/filter is intended for adult patients 3. whose respiratory status will not be compromised by the dead space.
Device Description
Not Found
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K Number
K010271Device Name
THINKINGNET
Manufacturer
THINKING SYSTEMS CORP.
Date Cleared
2001-04-03
(64 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
THINKING SYSTEMS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010040Device Name
SLEEVED FILTER
Manufacturer
KING SYSTEMS CORP.
Date Cleared
2001-03-09
(63 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
KING SYSTEMS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sleeved Filter or Sleeved HME/Fitter is used to reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve.
Device Description
Sleeved Filter, Sleeved HME/Filter.
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K Number
K990614Device Name
HME-BOOSTER
Manufacturer
KING SYSTEMS CORP.
Date Cleared
2000-05-23
(453 days)
Product Code
BTT, DAT
Regulation Number
868.5450Why did this record match?
Applicant Name (Manufacturer) :
KING SYSTEMS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HME-Booster™ makes it possible to feed additional moisture into the system during rne innie Dooter - manoon p specifically when the use of an HME alone is no longer adequate due to a patient's moisture deficit. Only use the Booster T-piece when the Booster heating element is used. The HME-Booster™ can be used with HME's for anesthesia and HME's for ICU, at flow rates between 2L and 12L per minute. The HMEanoother and hime sole purpose of optimizing the output of the HME. It can only be used at any time in combination with an HME. Not for use with pediatric applications, where at any time in combination or equal to 250 ml and the body weight is less than 20 kg.
Device Description
Not Found
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K Number
K983817Device Name
BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)
Manufacturer
KING SYSTEMS CORP.
Date Cleared
1999-03-01
(123 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
KING SYSTEMS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended use for all models is the same. Different products are offered for variations in size. Specifically, MS-101 is for use in pediatric cases; MS-111 and VIS-121 are for use in cases where a larger dead space is not a concern for the physician.
Indications For Use:
1. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.
2. A Heat and Moisture Exchanger (HME) is a device intended to be positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by a patient during anesthesia and ventilator care.
Device Description
Device name: Bacterial/Viral filter and HME combination device.
Product numbers: MS-101, MS-111, MS-121
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K Number
K973797Device Name
BREATHING CIRCUIT BACTERIAL FILTER
Manufacturer
KING SYSTEMS CORP.
Date Cleared
1998-03-12
(157 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
KING SYSTEMS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A bacterial filter is indicated for use when the care provider desires to protect the patient, care provider, equipment, or all three from the transference of bacteria or virus through the breathing circuit. This filter is provided only in combination with a King Systems Universal F2™ breathing circuit. Within this combination the overall intended use is to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
Device Description
Breathing Circuit Bacterial Filter
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