IMIX INSIGHT X-RAY SYSTEMS

• K Number: K073114
• Device Name: IMIX INSIGHT X-RAY SYSTEMS
• Manufacturer: IMIX ADR FINLAND OY
• Date Cleared: 2008-01-17 ( 73 days)
• Product Code: KPR
• Regulation Number: 892.1680
• Type: Special
• Panel: RA
• Reference & Predicate Devices: K071193 , K974863 , K042876

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 .

AI/ML Overview

The provided text (K073114) describes an X-ray system called the IMIX Insight X-Ray System. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies or effect sizes.
6. Information about standalone algorithm performance studies.
7. The type of ground truth used.
8. The sample size for the training set.
9. How ground truth for the training set was established.

The document primarily states:

• Device Name: IMIX Insight X-Ray Systems
• Intended Use: Generating radiographic images of human anatomy, replacing radiographic film/screen systems in general-purpose diagnostic procedures. Not indicated for diagnostic X-ray mammography.
• Substantial Equivalence: The device is a modified combination of a cleared device (IMIX Digital Thorax K974863) with exempt devices, and is functionally identical to the SEDECAL URS LP X-Ray Units with Digital Detector (K042876) and similar to Vidar Vision 3000 and 4000 (K071193).
• Device Description: Provides details about system features like the URS Radiographic Stand, X-Ray Subsystem, and IMIX Insight Detector specifications (e.g., 9 or 16 megapixel CCD detector, 40cm x 40cm image format, spatial resolution >3.1 lp/mm or >4.3 lp/mm, 16-bit image acquisition).

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.