(29 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on standard digital X-ray system functionality.
No
The device is described as a diagnostic imaging system (digital X-ray general radiography systems) used to perform radiographic exposures for image acquisition, not for treating a condition.
Yes
Explanation: The device is an X-ray system that produces radiographic images for doctors or technicians to preview and store. These images are used to identify or characterize diseases or conditions, which is a diagnostic function.
No
The device is described as a "digital X-ray general radiography system" and "Digital Radiology Systems," which are hardware systems that perform radiographic exposures. While they produce digital images and have software components for image handling, the core device is a physical X-ray machine.
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 about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The AN6255 and AN6265 are digital X-ray systems. They use radiation to create images of the inside of the body (in vivo). They do not analyze biological specimens.
- Intended Use: The intended use clearly states they are for performing radiographic exposures of the whole body. This is a diagnostic imaging procedure, not an in vitro test.
Therefore, based on the provided information, this device falls under the category of diagnostic imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The AN6255 and AN6265 are digital X-ray general radiography systems intended for use by qualified/trained doctor or technician and are designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremitties and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.
Images from these systems are available for preview by the doctor/X-ray technician on the operator's workstation within seconds of the x-ray exposure. Digital (DICOM) images can be stored on electronic media, or exported to a (DICOMPACS) network, clinical review station or to a film printer.
Product codes
KPR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital X-ray
Anatomical Site
whole body including skull, spinal column, chest, abdomen, extremitties and other body parts excluding mammography.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
JUN 2 1 2007
510(k) Summary For Analogic Corporation AN6255 and AN6265 Digital Radiology Systems
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92
Submitter's Name and Address:
Analogic Corporation 8 Centennial Drive Peabody, MA 01960
Date this Summary was Prepared:
Error! Reference source not found.
Contact Person:
| Donald J Sherratt, Director of Corporate Regulatory Affairs | |
|---|---|
| Tel: | (978) 326-4000 extension 4075 |
| Fax: | (978) 977-6808 |
Device Name:
| Proprietary or Trade Name: | AN6255 and AN6265 (SyneRad Omni) |
|---|---|
| Common Name: | Digital Radiology Systems |
| Classification Name: | Digital Radiology Systems and Accessories |
| Device Classification: | Class II |
Predicate Device:
The legally marketed devices to which equivalence is being claimed are:
The Analogic AN6250 Digital Radiology System. The predicate system was cleared under Premarket Notification K043025.
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is a stylized graphic of three overlapping human figures.
JUN 2 1 2007
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Donald J. Sherratt Director of Corporate Regulatory Affairs Analogic Corporation Centennial Industrial Park 8 Centennial Drive PEABODY MA 01960
Re: K071430
Trade/Device Name: AN6255 and AN6265 Digital Radiology Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR . Dated: May 21, 2007 Received: May 23, 2007
Dear Mr. Sherratt:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/10 description: The image shows a logo with the letters FDA in bold, surrounded by the words "Centennial" and "Protecting and Promoting Public Health". The logo also includes the years 1906-2006. The text is in a decorative font, and the overall design is reminiscent of a seal or emblem. The image appears to be a scan of a document.
2
Page 2 -
Enclosure
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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
NALOGIC.
510(k) Number K071430.
Device Name: AN6255 and AN6265 Digital Radiology Systems
Indications For Use:
The AN6255 and AN6265 are digital X-ray general radiography systems intended for use by qualified/trained doctor or technician and are designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremitties and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.
Images from these systems are available for preview by the doctor/X-ray technician on the operator's workstation within seconds of the x-ray exposure. Digital (DICOM) images can be stored on electronic media, or exported to a (DICOMPACS) network, clinical review station or to a film printer.
Helene Lewis
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number
| Prescription Use | X |
|---|---|
| (21 CFR 801 Subpart D) | |
| AND/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 (ODE)