Search Results
Found 3 results
510(k) Data Aggregation
K Number
K093596Device Name
LUMOS, MODEL R 72B
Manufacturer
LUMOS, INC
Date Cleared
2010-01-12
(53 days)
Product Code
KPW
Regulation Number
892.1610Why did this record match?
Product Code :
KPW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Model R 72B Manual X-RAY Collimator is intended for use in diagnostic radiographic or fluoroscopic applications fluoroscopic applications.
Device Description
This is a compact collimator with an external cover in ABS plastic. It is a single-layer, square field radiological collimator. Its light weight and compact size allow cass. positioning and make it ideal for mobile and portable units. The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator and by o yead disc near the x-ray focus to reduce scattered radiation. An indexed scale provides information on the field set with the knobs.
Ask a Question
K Number
K062788Device Name
COLLIMATOR, MODEL M-38
Manufacturer
UMI INTERNATIONAL
Date Cleared
2006-12-28
(101 days)
Product Code
KPW
Regulation Number
892.1610Why did this record match?
Product Code :
KPW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A diagnostic x-ray beam-limiting device intended to restrict the dimension of a diagnostic x-ray field by limiting the size of the primary x-ray beam coming from x-ray system.
Device Description
Collimator (manual drive) – a beam limiting device
Ask a Question
K Number
K030487Device Name
R 72
Manufacturer
RALCO S.R.L.
Date Cleared
2003-08-01
(168 days)
Product Code
KPW
Regulation Number
892.1610Why did this record match?
Product Code :
KPW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Model R72 is intended to be used as an X-Ray beam limitation device on portable and mobile diagnostic X-Ray units.
Device Description
R72 X-Ray Collimator: External cover in abs plastic Single-layer, square field radiological collimator. Focus/mounting flange plane distance is 70mm. The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator, a lead cone situated near the x-ray anode reduces the off-focus radiation. Its light weight and compact size allow easy positioning and make it ideal for portable units. A table on the front panel allows the operator to read field dimensions set with the knobs.
Ask a Question
Page 1 of 1