(39 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard digital X-ray functionality.
No
The device is described as a 'general radiography system' intended for performing 'radiographic exposures' to generate images for diagnosis, not for therapeutic intervention.
Yes
The device is described as a "digital X-ray general radiography system" that performs "radiographic exposures" to produce images of various body parts. These images are then available for "preview by the doctor / x-ray technician" for potential "clinical review," which indicates its use in the diagnostic process. Furthermore, one of the performance studies mentioned "General requirements for radiation protection in diagnostic X-ray equipment," explicitly linking it to diagnostic use.
No
The device is described as a "digital X-ray general radiography system," which inherently includes hardware components for generating and capturing X-rays, in addition to any software for image processing and display. The performance studies also mention testing against hardware safety standards like IEC 60601.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The AN6150 is a digital X-ray system. It uses radiation to create images of the inside of the human body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for performing radiographic exposures of the whole body. This is an in vivo (within the living body) diagnostic imaging technique, not an in vitro diagnostic test.
Therefore, the AN6150 falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The AN6150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities 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 the AN6150 are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure. After acceptance, by the operator the digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
Product codes (comma separated list FDA assigned to the subject device)
90 KPR
Device Description
The AN6150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities 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 the AN6150 are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure. After acceptance, by the operator the digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
whole body including skull, spinal column, chest, abdomen, extremities 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)
The design of the AN6150 Digital Radiology System has been thoroughly validated at the unit and system level and meets all elements of its Requirements Specification. This included the following non-clinical tests:
- IEC 60601-1:1988, +A1:1991, +A2:1995, an FDA recognized consensus . standard for safety of medical electrical equipment.
- IEC 60601-1-1: .
- . IEC 60601-1-3:1994, Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
- . IFC 60601-2-7:
- IEC 60601-2-28 .
- IEC 60601-2-32: .
- IEC 60601-1-2:2001, an FDA recognized consensus standard for electromagnetic . compatibility.
- Line Dropout and Variation Susceptibility were tested according to the FDA . Reviewer Guidance for Remarket Notification Submissions, November 1993 Mechanical Shock and Vibration Tests
- Shipping Container Transportation Test .
All tests passed the stated criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string appears to be "K040995". The characters are written in a bold, somewhat stylized font, with some variation in stroke thickness. The overall impression is that of a quickly written or stylized code or identifier.
Image /page/0/Picture/2 description: The image shows the word "ANALOGIC" in a bold, sans-serif font. The letters are black and appear to be slightly distressed, giving them a textured look. To the right of the word is a black square, which is a part of the company's logo. The registered trademark symbol is present next to the "C" in "ANALOGIC."
510(k) Summary For Analogic Corporation AN6150 Digital Radiology System
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:
April 15, 2004
Contact Person:
| Donald J Sherratt, Regulatory Affairs Manager | |
|---|---|
| Tel: | (978) 977-3000 extension 3049 |
| Fax: | (978) 977-6808 |
Device Name:
| Proprietary or Trade Name: | AN6150 Digital Radiology System |
|---|---|
| Common Name: | Digital Radiology Systems |
| Classification Name: | Digital Radiology Systems and Accessories |
Predicate Device:
The legally marketed devices to which equivalence is being claimed are:
The Analogic AN5150 and AN7150 Digital Radiology Systems. These systems were cleared under Premarket Notification K033345.
Device Description:
Intended Use
The AN6150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities 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 the AN6150 are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure. After acceptance, by the operator the digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
1
Comparison of Technological Characteristics:
The design of the new AN6150 Digital Radiology System is derived from the design of the Digital Radiology Systems AN5150 and AN7150.
Voluntary Standards Used in Determination of Substantial Equivalence:
The design of the AN6150 Digital Radiology System has been thoroughly validated at the unit and system level and meets all elements of its Requirements Specification. This included the following non-clinical tests:
- IEC 60601-1:1988, +A1:1991, +A2:1995, an FDA recognized consensus . standard for safety of medical electrical equipment.
- IEC 60601-1-1: .
- . IEC 60601-1-3:1994, Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
- . IFC 60601-2-7:
- IEC 60601-2-28 .
- IEC 60601-2-32: .
- IEC 60601-1-2:2001, an FDA recognized consensus standard for electromagnetic . compatibility.
- Line Dropout and Variation Susceptibility were tested according to the FDA . Reviewer Guidance for Remarket Notification Submissions, November 1993 Mechanical Shock and Vibration Tests
- Shipping Container Transportation Test .
All tests passed the stated criteria.
Conclusions From Nonclincal Testing
The testing of the AN6150 Digital Radiology System demonstrates that the performance is substantially equivalent to the predicate devices cited above.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2004
Mr. Donald J. Sherratt Regulatory Affairs Manager Analogic Corporation 8 Centennial Drive PEABODY MA 01960
Re: K040995 Trade/Device Name: AN6150 Digital Radiology System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 KPR Dated: April 15, 2004 Received: April 26, 2004
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 (PMA), 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.
Please be advised that I'DA'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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and in your to begin finding of substantial equivalence of your device to a legally premaired predicated 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 If you desire spoolite at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Othphanes an ( notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or 11anakaotarero, Int at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Boyden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
ANALOGIC®
510(k) Number:
Device Name: AN6150 Digital Radiology System
Indications For Use:
The AN6150 is a digital X-ray general radiography system intended for use by qualified/trained The FINOTS Is a dignal ITTLy gollers to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities 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 the AN6150 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 (DICOM/PACS) network, clinical review station or to a film printer.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | OR | Over-The-Counter Use ______ |
| (Per 21 CFR 801.109) |
| Nancy Brogdon | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K040995 |