(30 days)
Not Found
No
The summary describes a standard digital X-ray system and does not mention any AI or ML capabilities for image analysis, processing, or interpretation.
No
The device is described as a digital X-ray system for performing radiographic examinations, which are diagnostic procedures, not therapeutic.
No
The device is an X-ray system that produces images for review, but it does not perform the diagnosis itself. The diagnosis is made by a qualified doctor or technician based on the images.
No
The device description clearly states it is a "digital X-ray chest system" and a "digital X-ray general radiography system," which are hardware devices that perform radiographic exposures. While it mentions image processing and display on a workstation, the core device is the X-ray system itself, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The AN5150 and AN7150 are digital X-ray systems. They use radiation to create images of the internal structures of the body. This is an in vivo (within the living body) diagnostic method, not in vitro.
- Intended Use: The intended use clearly states they are for performing radiographic examinations of various body parts. This involves imaging the patient directly, not analyzing samples taken from the patient.
Therefore, these devices fall under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The AN5150 is a digital X-ray chest system intended for use by qualified/trained doctor or technician and is designed to perform radiographic chest examinations.
The AN7150 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 AN5150 or AN7150 become available for preview by the doctor /x-ray technician on the operator's workstation seconds after the x-ray exposure. After acceptance 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
KPR
Device Description
The AN5150 is a digital X-ray chest system intended for use by qualified/trained doctor or technician and is designed to perform radiographic chest examinations.
The AN7150 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
chest, 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 AN5150 and AN7150 Digital Radiology Systems has been thoroughly validated at the unit and system level and meets all element of its Requirements Specification. This included the following non-clinical tests:
- . IEC 60601-1, an FDA recognized consensus standard for safety of medical electrical equipment.
- Electromagnetic Emissions Tests to determine if it was in compliance with the EN 55011, Group 1, and Class B emissions limits.
- . IEC 60601-1-2, an FDA recognized consensus standard for electromagnetic compatibility.
- Line Dropout and Variation Susceptibility were tested according to the . FDA Reviewer Guidance for PreMarket 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
510(k) Summary For Analogic Corporation AN5150 and AN7150 Digital Radiology Systems
DATE THIS SUMMARY WAS PREPARED:
October 14, 2003
SUBMITTER'S NAME AND ADDRESS:
Analogic Corporation 8 Centennial Drive Peabody, MA 01960
CONTACT PERSON:
| Marvin Rosenbaum, Regulatory Affairs Manager | |
|---|---|
| Telephone | (978) 977-3000 extension 3049 |
| Facsimile | (978) 977-6808 |
DEVICE NAME:
Proprietary or Trade Name: AN5150 and AN7150 Digital Radiology Systems Digital Radiology Systems Common Name: Digital Radiology Systems and Accessories Classification Name:
PREDICATE DEVICE:
The legally marketed devices to which equivalence is being claimed is:
The Analogic DR 5000 and DR 9000 Digital Radiology Systems that was cleared under Premarket Notification K001341 & K001336 respectively and the Sterling Diagnostic DirectRay Operator Console cleared under Premarket Notofication K980970.
DEVICE DESCRIPTION: INTENDED USE
The AN5150 is a digital X-ray chest system intended for use by qualified/trained doctor or technician and is designed to perform radiographic chest examinations.
The AN7150 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.
1
Images from the AN5150 or AN7150 become available for preview by the doctor /x-ray technician on the operator's workstation seconds after the x-ray exposure. After acceptance digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
COMPARISION OF TECHNOLICICAL CHARACTERISTICS:
The design of the AN5150 and AN7150 Digital Radiology Systems is derived from the design of the Digital Radiology Systems The DR 5000 and DR 9000.
NONCLINICAL TEST USED IN DETERMINATION OF SUBSTANIAL EQUIVALENCE:
The design of the AN5150 and AN7150 Digital Radiology Systems has been thoroughly validated at the unit and system level and meets all element of its Requirements Specification. This included the following non-clinical tests:
- . IEC 60601-1, an FDA recognized consensus standard for safety of medical electrical equipment.
- Electromagnetic Emissions Tests to determine if it was in compliance with the EN 55011, Group 1, and Class B emissions limits.
- . IEC 60601-1-2, an FDA recognized consensus standard for electromagnetic compatibility.
- Line Dropout and Variation Susceptibility were tested according to the . FDA Reviewer Guidance for PreMarket 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 AN5150 and AN7150 Digital Radiology Systems 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 Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2003
Mr. Marvin Rosenbaum Regulatory Affairs Manager Analogic Corporation 8 Centennial Drive PEABODY MA 01960
Re: K033345
Trade/Device Name: AN5150 and AN7150 Digital Radiology Systems Regulation Number: 21 CFR§ 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: 90 KPR Dated: October 10, 2003 Received: October 20, 2003
Dear Mr. Rosenbaum:
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 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 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.
3
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 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 Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number Ko3334 >
Device Name: AN5150 and AN7150 Digital Radiology Systems
Indications For Use:
The AN5150 is a digital X-ray chest system intended for use by qualified/trained doctor or technician and is designed to perform radiographic chest examinations.
The AN7150 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 AN5150 or AN7150 become available for preview by the doctor /x-ray technician on the operator's workstation seconds after the x-ray exposure. After acceptance digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
David A. Segura
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use J OR Over-The-Counter Use (Per 21 CFR 801.109)
Analogic Corporation AN5150 and AN7150 Digital Radiology Systems 510(k) October 14, 2003 Page vii of xi