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510(k) Data Aggregation
K Number
K092943Device Name
ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE
Manufacturer
Date Cleared
2009-12-11
(78 days)
Product Code
Regulation Number
872.6770Why did this record match?
Applicant Name (Manufacturer) :
**ARNOLD **TUBER INDUSTRIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Cartridge Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
Device Description
Dental Aspirating Syringes/Self Aspirating Syringes include standard, petite and medium sizes. All syringes are made of stainless steel and have aluminum handles. Syringes are reusable, sterilizable and packaged non-sterile.
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K Number
K993283Device Name
OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C
Manufacturer
Date Cleared
1999-12-29
(90 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
**ARNOLD **& RICHTER CINE TECHNIK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pacs Unit ARRI OSCAR NET/CD will be used to acquire, display, process, archive, retricve, and transmit diagnostic medical images and information about these images in a single user or network enviroment. The typical users are trained medical professionals.
Device Description
The device is intendet to be used to convert an medical film/S-VHS Tape -Image into a digital format(DICOM), electronic storage for an medical image and electronic tranfer of medical image data.
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K Number
K973115Device Name
ARRIPRO 35 ST/TV
Manufacturer
Date Cleared
1997-09-02
(13 days)
Product Code
Regulation Number
892.1890Why did this record match?
Applicant Name (Manufacturer) :
**ARNOLD **& RICHTER CINE TECHNIK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is used for the diagnosis and quantitative. evaluation of 35 mm cine radiographic images, which i originating from radiographic imaging like Angiography.
The device contains a visible light source covered with a translucent front that is intended to be used to view medical cine radiographic images (CFR 21 part 892.1890). It also allows to be used for wall projection. The medical device is not part of a diagnostic x-ray system.
The device may only be operated in cathlabs, lecture halls and doctors' consulting rooms. The device is only for use by medical professionals.
Device Description
The ARRIPRO 35 was designed to fulfil the special requirements in view of an increasing demand for image quality and evaluation precision of 35 mm cardangiofflm material which could only be met with the innovative development of a practice-oriented projector. This projector which was developed using state-of-the-art technology for ease of operation, has an outstanding image quality for the projection, diagnosis and quantitative evaluation of 35 mm cine radiographic images.
The ARRIPRO 35 St / TV has the following functions: Rapid Film Transport and Simple Operation, Optimized Image Quality with Flicker Free Projection, High Speed Shuttle, Revolving Lamp Holder, Optimum Wall Projection, Computer and Video Connections, B&W-CCD-TV Camera.
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