EOS

K071546 · Biospace Med · KPR · Sep 18, 2007 · Radiology

Device Facts

• Record ID: K071546
• Device Name: EOS
• Applicant: Biospace Med
• Product Code: KPR · Radiology
• Decision Date: Sep 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography, and mammography. EOS allows the radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient in the upright or seated position.

Device Story

EOS is a digital radiography system; utilizes two sets of xenon gas-filled digital detectors and X-ray tubes positioned orthogonally; captures frontal and lateral images simultaneously in a single scan; patient positioned upright or seated. System stores diagnostic images in a database; displays on high-resolution medical-quality monitor for physician diagnosis. Images transmitted via DICOM 3.0 network for archiving/printing. Used in clinical settings; operated by radiology staff. Provides diagnostic radiographic images to assist clinicians in general radiographic examinations.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 and collateral standards confirmed. Additional testing demonstrated equivalent performance compared to predicate devices.

Technological Characteristics

Digital radiography system; two sets of xenon gas-filled digital detectors and X-ray tubes; orthogonal configuration for simultaneous frontal/lateral imaging; DICOM 3.0 network connectivity; high-resolution monitor display; complies with IEC 60601-1.

Indications for Use

Indicated for general radiographic examinations of patients in upright or seated positions; whole body or reduced area imaging; excludes lung nodule evaluation, fluoroscopy, angiography, and mammography.

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

• Lodox Digital Radiography System (K013999)
• Toshiba's Auklet CT scanner TSX-003-A (K973908)
• GE Televix 1600 (K790692)
• Philips Bucky Diagnost System (K945278)
• CGR Prestilix (K843926)
• Kodak DirectView CR 900 System (K020635)
• Siemens DR Thorax/Multix FD (K983732)

Reference Devices

• AGFA Cornex 5 film
• AGFA Curix-Ortho HT-G film

Submission Summary (Full Text)

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K071546

## 510(k) SUMMARY

# Biospace Med's EOS

SEP 1 8 2007

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Biospace Med 10 rue Mercoeur Paris F-75011 France

Phone: [phone] Facsimile: [phone]

Contact Person:Karine Chevrie

Date Prepared: June 5, 2007

Trade Name: EOS

Common or Usual Name: Digital Radiography System

Classification Name: Radiology

## Predicate Devices

- The Lodox Digital Radiography System (K013999) .
- . Toshiba's Auklet CT scanner TSX-003-A (K973908)
- GE Televix 1600 (K790692) with AGFA Cornex 5 film .
- Philips Bucky Diagnost System (K945278) with AGFA Curix-Ortho HT-G film .
- CGR Prestilix (K843926) + Kodak DirectView CR 900 System (K020635) .
- Siemens DR Thorax/Multix FD (K983732) ◆

# Intended Use / Indications for Use

The EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography, and mammography. EOS allows the radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient in the upright or seated position.

# Technological Characteristics

EOS is a digital radiography system in which two sets of xenon gas filled digital detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously. The diagnostic images are stored in a database and are displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed. The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing and archiving. This device employs the same technological characteristics as the predicate devices differing only in the specifics of subassembly component composition.

## Performance Data

EOS is designed to comply with IEC 60601-1 and collateral standards.

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Additional testing confirmed the equivalent performance of the EOS as compared to the claimed predicate devices.

# Substantial Equivalence

EOS is as safe and effective as conventional radiography systems. EOS has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between EOS and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that EOS is as safe and effective as common radiography systems. Thus, EOS is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Biospace Med % Mr. John J. Smith Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, NW WASHINGTON DC 20004

AUG 2 0 2013

Re: K071546

Trade/Device Name: EOS Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: August 9, 2007 Received: August 10, 2007

Dear Mr. Smith:

This letter corrects our substantially equivalent letter of September 18, 2007.

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

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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 nredicate 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 [phone]. 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 [phone] or [phone] 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

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## Indications for Use Statement

KO71546 510(k) Number (if known):_

Device Name: EOS

The EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography, and mammography, EOS allows the radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient in the upright or seated position.

Prescription Use __ X AND/OR (Part 21 C.F.R. 801 Subpart D)

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

CDRH, Office of Device Evaluation (ODE)

Concurrence of

Hubert Leinen

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

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