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510(k) Data Aggregation
K Number
K992896Device Name
DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)
Manufacturer
Date Cleared
1999-09-03
(7 days)
Product Code
Regulation Number
892.1900Why did this record match?
Product Code :
EGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DXSS Automatic X-ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. This is the sole purpose of this device.
Device Description
Dental automatic radiographic film processor
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K Number
K955825Device Name
SMITH S-100 TIME & TEMPERATURE CONTROL
Manufacturer
Date Cleared
1996-04-05
(101 days)
Product Code
Regulation Number
892.1900Why did this record match?
Product Code :
EGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K955643Device Name
ALARA IMAGING SYSTEM
Manufacturer
Date Cleared
1996-03-01
(80 days)
Product Code
Regulation Number
892.1900Why did this record match?
Product Code :
EGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ALARA Imaging System is indicated for use digital dental radiography system for using X-ray recording media (phosphor storage screens) for radiographic diagnostic intraoral and extraoral exposures providing interactive CRT retrieval, viewing and processing of stored computed radiographic images.
Device Description
The ALARA Imaging System is digital dental radiography system for using X-ray recording media (phosphor storage screens) for radiographic diagnostic intraoral and extraoral dental images.
ALARA Imaging System is comprised of the following main components:
- Reusable phosphor storage screens (Denta-screens) with commercially available disposable storage screen covers;
- . The ALARA Scanner, an image reader/digitizer (laser scanner and optical reader);
- The ALARA Scanner/Workstation Communications Interface;
- The ALARA Imaging System Workstation, with a CRT monitor, a workstation computer (the image processor), a keyboard and mouse (operator interface), proprietary workstation software, a floppy drive, and an optical hard drive (or digital analog tape) that is either resident in or attached to the workstation computer (image storage devices);
- A compatible commercially available laser printer (hard copy device); .
- A commercially available light box used to "erase" the phosphor storage screen "eraser"; and
- . Any compatible commercially available mass storage device(s) as backup electronic archive device(s).
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