FDA INDICATIONS

Spectron IR Medical Infrared Imaging System

FDA 510(k) Indications for Use

FDA 510(k) #KO32471

Indications for use: The Spectron IR Clinical Infrared Imaging System is intended for adjunctive diagnostic screening for the detection of breast cancer and other uses such as: peripheral vascular disease, neuromusculoskeletal disorders, extracranial cerebral and facial vascular disease, thyroid gland abnormalities, and various other neoplastic, metabolic and inflammatory conditions.

640 IR Entry Package

  1. 640×480 VOx Radiometric Microbolometer
  2. Thermo Sensitivity/NEDT: less than 50mK
  3. Frame rate: 30Hz
  4. Spectral Range: 8-12 microns
  5. Computer interface: Digital (Ethernet)
  6. Software Controlled Electronic Focus
  7. Focusing distance: 1 – 15ft

Package includes

  1. Dedicated Computer with pre-loaded software
  2. On-line training (certified course available)
  3. Spectron IR professional medical software
  4. No annual fees or hidden costs

 

640 IR Basic Package

  1. 640×480 VOx Radiometric Microbolometer
  2. Thermo Sensitivity/NEDT: less than 50mK
  3. Frame rate: 30Hz
  4. Spectral Range: 8-12 microns
  5. Computer interface: Digital (Ethernet)
  6. Software Controlled Electronic Focus
  7. Focusing distance: 1 – 15ft

Package includes

  1. Dedicated Computer with pre-loaded software
  2. On-line training (certified course available)
  3. Spectron IR 2-pole camera stand
  4. Spectron IR professional medical software
  5. No annual fees or hidden costs

 

640 IR Medical Imaging Workstation

  1. 640×480 VOx Radiometric Microbolometer
  2. Thermo Sensitivity/NEDT: less than 50mK
  3. Frame rate: 30Hz
  4. Spectral Range: 8-12 microns
  5. Computer interface: Digital (Ethernet)
  6. Software Controlled Electronic Focus
  7. Focusing distance: 1 – 15ft

Package includes

  1. Dedicated Computer with pre-loaded software
  2. On-line training (certified course available)
  3. Spectron IR U.S. Patent Pro Cart
  4. Spectron IR professional medical software
  5. No annual fees or hidden costs

 

640 IR Wall Mounted Package

  1. 640×480 VOx Radiometric Microbolometer
  2. Thermo Sensitivity/NEDT: less than 50mK
  3. Frame rate: 30Hz
  4. Spectral Range: 8-12 microns
  5. Computer interface: Digital (Ethernet)
  6. Software Controlled Electronic Focus
  7. Focusing distance: 1 – 15ft

Package includes

  1. Dedicated Computer with pre-loaded software
  2. On-line training (certified course available)
  3. Spectron IR wall mount
  4. Spectron IR professional medical software
  5. No annual fees or hidden costs