Search Results
Found 4 results
510(k) Data Aggregation
K Number
K113855Device Name
PANORAD, PANORAD SL
Manufacturer
IMIX ADR FINLAND OY
Date Cleared
2012-01-25
(27 days)
Product Code
KPR, LLZ, MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
IMIX ADR FINLAND OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMIX PanoRad and PanoRad SL X-Ray Systems are indicated for use in generating radiographic images of human anatomy. They have Solid State X-ray Imaging systems intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (Not for mammography.)
Device Description
The modified device can produce digital x-ray images in various configurations.
Ask a Question
K Number
K101435Device Name
IMIX PANORAD AND SOMARAD
Manufacturer
IMIX ADR FINLAND OY
Date Cleared
2010-09-15
(117 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
IMIX ADR FINLAND OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMIX PanoRad and SomaRad X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (Not for mammography.)
Device Description
The PanoRad consists of: A high resolution CCD detector with 14" x 17" or 17" x 17" image area. An X-Ray Tube & Collimator. A fully motorized positioned. A 65 kW high frequency generator. A 4 way floating table. An Image Acquisition workstation with DICOM 3 compliance.
The SomaRad consists of: A high resolution CCD detector with 14" x 17" or 17" x 17" image area. An X-Ray Tube & Collimator. A fully motorized positioned. A 50 kW high frequency generator. A table. An Image Acquisition workstation with DICOM 3 compliance.
Ask a Question
K Number
K073114Device Name
IMIX INSIGHT X-RAY SYSTEMS
Manufacturer
IMIX ADR FINLAND OY
Date Cleared
2008-01-17
(73 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
IMIX ADR FINLAND OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMIX Insight X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. IMIX Insight X-Ray Systems are not indicated for diagnostic X-ray mammography.
Device Description
System Features
- URS Radiographic Stand .
- Fully motorized movements with intelligent anti-collision system .
- Automatic settings for 40 and 72 inch SID, auto-position for table exposures .
- Patient Table capacity of 440 lbs .
- Collimator with light field and laser positioning .
- X-Ray Subsystem 65 kW High Frequency Compact Generator .
- Full Anatomical Programming .
- Automatic Exposure Control .
- High Capacity (300kHU) X-ray tube with 0.6/1.2mm focus (27/75kW) .
- Microprocessor System Monitor .
- IMIX Insight Detector: High Resolution 9 megapixel or 16 megapixel CCD detector .
- 40cm x 40cm Image Format (16 x 16 inch) .
- Spatial Resolution: >3.1 1p/mm (4Mp) or >4.3 1p/mm (16Mp) .
- Image Acquisition: 16 bit .
- 3 Field Ionization Chamber .
Ask a Question
K Number
K072867Device Name
IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K
Manufacturer
IMIX ADR FINLAND OY
Date Cleared
2007-11-21
(47 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
IMIX ADR FINLAND OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1