← Product Code [MQB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB) · K042821 # DIGITAL DETECTOR, MODEL GR17 (K042821) _Anrad Corp. · MQB · Oct 22, 2004 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K042821 ## Device Facts - **Applicant:** Anrad Corp. - **Product Code:** [MQB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB.md) - **Decision Date:** Oct 22, 2004 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 892.1680 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** 3rd-Party Reviewed ## 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. ## Device Story GR17 is an amorphous Selenium-based direct conversion digital radiography (DR) detector; 17x17 inch form factor. Device converts incident X-rays directly into electrical signals to create diagnostic radiographic images. Operated by qualified doctors or technicians in clinical settings. Replaces traditional film/screen systems for general purpose diagnostic imaging. Output provides digital images for clinical review and decision-making, facilitating diagnostic assessment of human anatomy. ## Clinical Evidence Clinical study report dated September 8, 2004, concluded the device is substantially equivalent to the predicate devices. No specific performance metrics or sample sizes provided in the summary. ## Technological Characteristics Amorphous Selenium-based direct conversion digital radiography detector. Dimensions: 574mm x 502mm x 32.3mm; Weight: 10.5 kg. Stationary X-ray system component (21 CFR 892.1680). ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Sterling Diagnostic Imaging Direct Radiography ([K973206](/device/K973206.md)) - Fuji Computed Radiography System FCR9000HQ ([K951373](/device/K951373.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 - 1. Submitter's Name and Address: ANRAD CORPORATION 4950 Levy Street Saint-Laurent (Québec) Canada H4R 2P1 - 2. Date this Summary was Prepared: September 24, 2004 - 3. 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 #### 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). {1}------------------------------------------------ #### 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 {4}------------------------------------------------ # 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K042821](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K042821) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com