(10 days)
No
The document describes a standard digital radiography detector and does not mention any AI or ML capabilities. The focus is on image acquisition and conversion, not intelligent image processing or analysis.
No
The device is a diagnostic imaging detector used to generate radiographic images for diagnostic purposes, not to treat a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device "is designed to generate radiographic images of human anatomy" and "is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures." The "Device Description" also mentions its use for "diagnostic use."
No
The device description explicitly states it is a "digital detector" and describes its physical dimensions and function of converting X-rays into electrical signals, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The GR17 is a digital radiography detector. It works by converting X-rays that pass through the human body into electrical signals to create images. It does not analyze biological specimens.
- Intended Use: The intended use is to generate radiographic images of human anatomy for general purpose diagnostic procedures, replacing film/screen systems. This is an in-vivo imaging process, not an in-vitro diagnostic test.
The information provided clearly describes a device used for medical imaging of the body, not for testing samples from the body.
N/A
Intended Use / Indications for Use
The GR17 is an amorphous Selenium-based direct conversion Digital Radiography (DR) detector intended for use by a qualified/trained doctor or technician and is designed to generate radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
Product codes
MQB
Device Description
The GR17 is a 17 inch by 17 inch digital delector. It is intended to convert X-rays into efectrical signals to create usable images for diagnostic use. The dimensions of the GR 17 are below:
| Overall length | 574 mm |
|---|---|
| Overall width | 502 mm |
| Overall height | 32.3 mm |
| Weight | 10.5 kg |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital Radiography (DR)
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified/trained doctor or technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Clinical Study Report dated September 8, 2004, the GR17 Digital Detector is substantially equivalent to the predicate device.
The testing of the GR17 Digital Detector demonstrates that the performance is substantially equivalent to the predicate devices cited above.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K04.282i
OCT 2 2 2004
info@ 510(k) Summary For ANRAD CORPORATION
GR17 Digital Detector
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92
-
- Submitter's Name and Address:
ANRAD CORPORATION 4950 Levy Street Saint-Laurent (Québec) Canada H4R 2P1
- Submitter's Name and Address:
-
- Date this Summary was Prepared:
September 24, 2004
- Date this Summary was Prepared:
-
- Submission Correspondent:
Donald J Sherratt Regulatory Affairs Manager Analogic Corporation 8 Centennial Drive Peabody MA 01960 (978) 977-3000 extension 3049 Telephone Facsimile (978) 977-6808
- Submission Correspondent:
4. Device Name:
| Proprietary or Trade Name: | GR17 Digital Detector |
|---|---|
| Common Name: | Solid State X-Ray Imager (Flat Panel / Digital Imager) |
| Classification Name: | Solid State X-Ray Imager |
| Classification Panel: | Radiology |
ર. Predicate Devices:
The legally marketed devices to which equivalence is being claimed are:
The Sterling Diagnostic Imaging Direct Radiography (K973206) and the Fuji Computed Radiography System FCR9000HQ (K951373).
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6. Device Description
The GR17 is a 17 inch by 17 inch digital delector. It is intended to convert X-rays into efectrical signals to create usable images for diagnostic use. The dimensions of the GR 17 are below:
| Overall length | 574 mm |
|---|---|
| Overall width | 502 mm |
| Overall height | 32.3 mm |
| Weight | 10.5 kg |
Table 4: GR17 Dimensions
7. Intended Use
.
The GR17 is an amorphous Selenium-based direct conversion Digital Radiography (DR) detector intended for use by a qualified/trained doctor or technician and is designed to generate radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
Comparison of Technological Characteristics: 8.
The design of the GR17 Digital Detector has the same technological characteristics as the predicate devices.
9. Clinical and Non-Clinical Testing
9.1 Conclusions from Clinical Testing
Based on the Clinical Study Report dated September 8, 2004, the GR17 Digital Detector is substantially equivalent to the predicate device.
Conclusions from Non-clinical Testing 9.2
The testing of the GR17 Digital Detector demonstrates that the performance is substantially equivalent to the predicate devices cited above.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes a stylized human figure in blue, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The text is positioned to the right of the human figure. The logo is simple and professional, and it is easily recognizable.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Anrad Corporation % Mr. Daniel W. Lehtonen Staff Engineer-Medical Devices Intertek Testing Services NA. Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
AUG 2 3 2013
Re: K042821
Trade/Device Name: GR17 Digital Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 8. 2004 Received: October 12, 2004
Dear Mr. Lehtonen:
This letter corrects our substantially equivalent letter of October 22, 2004.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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rad
510(k) Number Ko42824
Device Name: GR17 Digital Detector
Indications For Use:
The GR17 is an amorphous Selenium-based direct conversion Digital Radiography (DR) detector intended for use by a qualified/trained doctor or technician and is designed to generate radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
Prescription Use x (21 CFR 801 Subpart D)
ARD/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODL)
David A. Lyon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices KD42821 510(k) Number
September 24, 2004 Page xvii of xxi