KALARE DIAGNOSTIC X-RAY TABLE SYSTEM

K110785 · Toshiba Medical Systems Coporation, Japan · JAA · May 27, 2011 · Radiology

Device Facts

• Record ID: K110785
• Device Name: KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
• Applicant: Toshiba Medical Systems Coporation, Japan
• Product Code: JAA · Radiology
• Decision Date: May 27, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Intended to be used as a universal diagnostic imaging system for radiographic and 1. fluoroscopic examinations, including general R&F and pediatric examinations. 2. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Device Story

KALARE (DREX-KL80) is a universal diagnostic X-ray imaging system for radiography and fluoroscopy. Device utilizes X-ray source and fluorescent scintillation to capture image data for medical diagnosis. Operated by physicians or technologists in clinical settings; supports gastrointestinal, endoscopic, non-vascular contrast, abdominal, and skeletal examinations. Patient positioning includes sitting, standing, prone, or supine. System provides diagnostic images to clinicians to facilitate medical decision-making and treatment planning.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and compliance with applicable performance standards (21 CFR Subchapter J, IEC60601-1, ISO 13485).

Technological Characteristics

X-ray diagnostic table system; utilizes fluorescent scintillation for image acquisition. Complies with 21 CFR 1020 (Federal Diagnostic X-ray Equipment Standard) and IEC60601-1. Designed under ISO 13485 quality system regulations.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic and fluoroscopic imaging of the whole body, including skull, spine, chest, abdomen, and extremities. Used by qualified doctors or technologists with patients in sitting, standing, prone, or supine positions.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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

• GE Precision 500D R&F X-ray (K081091)

Submission Summary (Full Text)

{0}------------------------------------------------

K110785

Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) KALARE (DREX-KL80)

# MAY 2 7 2011

## 510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS

- 1. SUBMITTER'S NAME Toshiba America Medical Systems, Inc.
- 2. ADDRESS 2441 Michelle Drive Tustin, CA. 92780-2068
- 3. CONTACT PERSON Paul Biggins Director, Regulatory Affairs [phone]
- 4. TRADE NAME(S): KALARE (DREX-KL80) X-Ray Diagnostic Table System

#### 5. COMMON NAME:

System, X-Ray, Fluoroscopic, Image-Intensified

- 6. DEVICE CLASSIFICATION: Class II (per 21 FR 892.1650)
- 7. PRODUCT CODE / DESCRIPTION: JAA - Image-Intensified Fluoroscopic X-ray System

#### 8. PERFORMANCE STANDARD:

21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard

#### 9. DEVICE DESCRIPTION:

The main function of the KALARE (DREX-KL80) is to perform fluoroscopy/radiography of the examinations of the gastrointestinal tract examination, support for endoscopy, nonvascular contrast study, general abdominal radiography and general skeletal radiography. Using fluorescent scintillation effects of X-rays that have passed through the patient's body. image information is obtained for medical diagnosis and treatment.

#### 10. SUMMARY OF INTENDED USES:

This system is designed for X-ray examinations of the gastrointestinal tract, support for endoscopy, non-vascular contrast study, general abdominal radiography, and general skeletal radiography. It provides physicians with the data required for the X-ray diagnosis.

{1}------------------------------------------------

## 11. SUBSTANTIAL EQUIVALENCE:

The KALARE (DREX-KL80) is of comparable type and is substantially equivalent to the GE Precision 500D R&F X-ray (K081091).

#### 12. SAFETY:

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 standards and its collateral standards. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via an initial report.

## 13. CONCLUSION

The KALARE (DREX-KL80) complies with the same or equivalent standards and has the same intended use as the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird or abstract shape, consisting of three curved lines.

## 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

Toshiba Medical Systems Corporation, Japan % Mr. Paul Biggins Director Regulatory Affairs/US Agent Toshiba America Medical Systems, Inc. 2441 Michelle Dr TUSTIN CA 92780

MAY 2 7 2011

Re: K110785

Trade/Device Name: KALARE (DREX-KL80) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: March 18, 2011 Received: March 21, 2011

Dear Mr. Biggins:

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

{3}------------------------------------------------

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(b) remarket notification. The FDA finding of substantial equivalence of your device to a logally 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 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 no [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

| Applicant: | Toshiba America Medical Systems |
|---------------------------|---------------------------------|
| 510(k) Number (if known): | |
| Device Name: | KALARE (DREX-KL80) |

## Indications For Use:

- Intended to be used as a universal diagnostic imaging system for radiographic and 1. fluoroscopic examinations, including general R&F and pediatric examinations.
- 2. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Prescription Use X (Part 21 CFR 801 Subpart D)

:

MAR 2011

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Off

Mary S Patil
(Printing Sign Off)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

SECTION 4: Indication for Use Page 1 of 1

ETOK Company Confidential

510(k): KALARE - DREX-KL80 Page 12 of 1405