SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250

K043025 · Analogic Corp. · KPR · Nov 19, 2004 · Radiology

Device Facts

• Record ID: K043025
• Device Name: SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250
• Applicant: Analogic Corp.
• Product Code: KPR · Radiology
• Decision Date: Nov 19, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AN6250 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 AN6250 Digital Radiology System 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.

Device Story

AN6250 is a stationary, general-purpose digital X-ray system. It captures radiographic images of the whole body (excluding mammography) using X-ray exposure. Operated by physicians or technicians in clinical settings, the system processes raw X-ray data into digital images. These images are displayed on an operator workstation for immediate preview. Following operator acceptance, images are stored locally or transmitted via DICOM/PACS network to clinical review stations or film printers. The device facilitates diagnostic imaging, enabling healthcare providers to visualize internal anatomy for clinical decision-making. Benefits include rapid image availability and digital workflow integration.

Clinical Evidence

Bench testing only. The device was validated at the unit and system level against Requirements Specifications and recognized consensus standards, including IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and radiation protection standards. No clinical data was required or provided.

Technological Characteristics

Stationary digital X-ray system. Components include X-ray source and digital detector. Connectivity via DICOM/PACS network. Complies with IEC 60601-1, 60601-1-1, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32, and 60601-1-2. Tested for mechanical shock, vibration, and line dropout susceptibility.

Indications for Use

Indicated for general radiographic imaging of the whole body, including skull, spine, chest, abdomen, and extremities, in patients of all ages. Excludes mammography. Intended for use by qualified clinicians or technicians with patients in sitting, standing, or recumbent positions.

Regulatory Classification

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

• Analogic AN6150 Digital Radiology System (K040995)

Submission Summary (Full Text)

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NOV 1 9 2004

Image /page/0/Picture/1 description: The image shows the word "ANALOGIC" in bold, black letters. To the right of the word is a registered trademark symbol. A black square is located to the right of the trademark symbol. The letters are sans-serif and appear to be a company logo.

K043825

## 510(k) Summary For Analogic Corporation AN6250 Digital Radiology System

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92

#### 1. Submitter's Name and Address:

Analogic Corporation 8 Centennial Drive Peabody, MA 01960

#### Date this Summary was Prepared: 2.

November 2, 2004

#### 3. Contact Person:

Donald J Sherratt, Regulatory Affairs Manager [phone] extension 3049 Tel: [phone] Fax:

#### Device Name: 4.

| Proprietary or Trade Name: | AN6250 Digital Radiology System |
|----------------------------|-------------------------------------------|
| Common Name: | Digital Radiology Systems |
| Classification Name: | Digital Radiology Systems and Accessories |
| Device Classification: | Class II |

#### 5. Predicate Device:

The legally marketed device to which equivalence is being claimed is the Analogic AN6150 Digital Radiology System. The predicate system was cleared under Premarket Notification K040995.

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#### Device Description: 6.

The AN6250 is a Stationary, General Radiology X-ray System.

#### Intended Use 7.

The AN6250 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 AN6250 Digital Radiology System 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.

#### Comparison of Technological Characteristics: 8.

The design of the new AN6250 Digital Radiology System is derived from the design of the AN6150 Digital Radiology System and uses the same technological principles.

#### Compliance with Voluntary Standards 9.

Before final market release, the AN6250 Digital Radiology System will be thoroughly validated at the unit and system level to meets all elements of its Requirements Specification. This includes 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
- . IEC 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 premarket Notification Submissions, November 1993
- Mechanical Shock and Vibration Tests .
- . Shipping Container Transportation Test

#### 10. Conclusion

Based on the similarity in construction to the predicate device, same technological characteristics and the same intended use, the device is substantially equivalent.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around an abstract symbol. The symbol resembles an eagle or a bird in flight, represented by three curved lines.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 9 2004

*Mr. Donald J. Sherratt Regulatory Affairs Manager Analogic Corporation 8 Centennial Drive Centennial Industrial Park PEABODY MA 01960

Re: K043025

Trade/Device Name: AN6250 Digital Radiology System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 KRP Dated: November 2, 2004 Received: November 3, 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 (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.

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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and by the FDA finding of substantial equivalence of your device to a legally prematice notification. "Thesalts 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 specifice of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 60 : 77). I ou may or man curers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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

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Image /page/4/Picture/0 description: The image shows the word "ANALOGIC" in bold, black letters. The letters are sans-serif and appear to be a custom font. To the right of the word is a registered trademark symbol and a black square. The background is white.

510(k) Number: Ko43025 25 ---

Device Name: AN6250 Digital Radiology System

Indications For Use:

The AN6250 is a digital X-ray general radiography system intended for use by qualified/trained The IIN0250 Is a creatived 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 AN6250 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.

Prescription Use ਮ (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)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043025