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510(k) Data Aggregation
K Number
K021245Device Name
DEGOTZEN SYNCHRO
Manufacturer
Date Cleared
2002-05-03
(14 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
THE GOTZEN GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The de Gotzen "synchro" Intraoral Dental X-Ray System is an Extraoral Source X-Ray System, intended to be used for dental radiographic examinations and diagnosis of the teeth, jaw, and oral structures.
Device Description
The de Gotzen synchro Intraoral Dental X-Ray System is comprised of the following main components:
- X-Ray tubehead and yoke .
- . Articulating arm
- Horizontal arm, standard length ●
- Wall Mount
- Electronic control timer (which may be mounted remotely) .
- 8" and 12" Collimating cones .
Optional components:
- . Horizontal arm, short length
- Horizontal arm, long length .
- . Rectangular collimating cone
The power supply (Timer) is regulated to provide a fixed 70kVp, and the x-ray target current is fixed at 8ma. Predefined exposure times may be selected directly through the control timer switchpads. The range of exposure time is 0.08 through 3.2 seconds
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