| Device |
calibration software for radiology displays |
| Regulation Description |
Radiologic quality assurance instrument. |
| Definition |
The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology. |
| Physical State |
The device is a software |
| Technical Method |
The device is software that is used with a compatible qualified display, general purpose host computer, and external colorimeter to perform measurements and calibration to meet visual quality control (QC) testing requirements for diagnostic radiology displays |
| Target Area |
no limitation except the device is not intended for mammography. |
| Regulation Medical Specialty |
Radiology |
| Review Panel |
Radiology |
|---|
| Product Code | SHN |
|---|
| Premarket Review |
Office of Radiological Health
(OHT8)
Radiological Imaging Devices and Electronic Products
(DHT8B)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
892.1940
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
| If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
