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510(k) Data Aggregation
K Number
K091628Device Name
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
Manufacturer
PROTEC GMBH & CO. KG
Date Cleared
2009-08-21
(78 days)
Product Code
IXW
Regulation Number
892.1900Why did this record match?
Applicant Name (Manufacturer) :
**PROTEC GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX are all Automatic X-Ray Film Processors (Regulation No. 892.1900).
The devices mentioned above are intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films.
This may be used in all general radiographic, diagnostic imaging procedures.
Device Description
Due to the precise roller transport system, both sheet and roller films can be processed. The automatic film registration is activated immediately when a film is fed in. The transport system starts running. The film material is developed, fixed, rinsed and dried. With the easy to operate micro-processor, the processing conditions can be adjusted to suit the various film and chemical types. The developing solutions are temperature-regulated, circulated and automatically replenished. The feed width of the OPTIMAX®, OPTIMAX® 2010 and ECOMAX™ is 35 cm, the bigger COMPACT™ 2 has 45 cm feed with. The smallest film format of all processors is 10*10 cm.
The photographic processing (developing) technique employed by the Automatic X-Ray Film Processor is the same as the predicate device. The film medium is mechanically transported for immersion in two chemical baths (developer and fixer), is rinsed in water, dried, and then ejected for viewing. The processors use mechanical rollers for transportation, the solutions are temperature-regulated, circulated and automatically replenished, and same additional functions (anti-crystallization cycle, stand-by mode). All are controlled by an integrated software.
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K Number
K992818Device Name
OPTIMAX/ COMPACT 2
Manufacturer
PROTEC GMBH & CO. KG
Date Cleared
1999-09-01
(12 days)
Product Code
IXW
Regulation Number
892.1900Why did this record match?
Applicant Name (Manufacturer) :
**PROTEC GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Automatic X-Ray Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films. This may be used in all general radiographic, diagnostic imaging procedures.
Device Description
Due to the precise roller transport system, both sheet and roller films can be processed. The automatic film registration is activated immediately when a film is fed in. The transport system starts running. The film material is developed, fixed, rinsed and dried. With the easy to operate micro-processor, the processing conditions can be adjusted to suit the various film and chemical types. The developing solutions are temperature-regulated, circulated and automatically replenished. The feed width of the OPTIMAX is 35 cm, the bigger COMPACT 2 has 45 cm feed with. The smallest film format of both processors is 10*10 cm. The photographic processing (developing) technique employed by the Automatic X-Ray Film Processor is the same as the predicate device. The film medium is mechanically transported for immersion in two chemical baths (developer and fixer), is rinsed in water, dried, and then ejected for viewing. The processors use mechanical rollers and guides for transportation, the solutions are temperature-regulated, circulated and automatically replenished, and same additional functions (anti-crystallization cycle, stand-by mode). Both are controlled by an integrated software.
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