SUINSA DIAGNOSTIC X-RAY SYSTEM

K083109 · Suinsa · KPR · Dec 4, 2008 · Radiology

Device Facts

• Record ID: K083109
• Device Name: SUINSA DIAGNOSTIC X-RAY SYSTEM
• Applicant: Suinsa
• Product Code: KPR · Radiology
• Decision Date: Dec 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the 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

Stationary diagnostic X-ray system; comprises Hercules generator (32-80 kW), NOVA ceiling-mounted tube stand, NET4000 series X-ray table, and NBS2100 Bucky wall stand. Operated by qualified doctors or technicians in clinical settings. System generates X-ray exposures for film-based image acquisition. Healthcare providers use resulting radiographs to visualize internal anatomy for diagnostic purposes, supporting clinical decision-making regarding patient condition. Benefits include standardized radiographic assessment of various body parts.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence supported by performance standards testing.

Technological Characteristics

Stationary X-ray system; high-frequency generator (32-80 kW); ceiling-mounted tube stand; Bucky wall stand; X-ray table. Film-based image acquisition. CSA listed to US standards. Complies with applicable IEC standards.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of the skull, spine, chest, abdomen, and extremities. Patient may be positioned sitting, standing, prone, or supine.

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

• Almana Medical Radvision ET Diagnostic X-Ray Systems (K082064)

Submission Summary (Full Text)

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#### 510(k) Summary

## K08 3104

Image /page/0/Picture/3 description: The image contains a logo with the word "Suiinsa" in bold, sans-serif font. Below the word is the phrase "YOUR IMAGING PARTNER" in a smaller font size. There is a black rectangle below the phrase. The image appears to be a company logo or branding element.

## SUINSA C/Primavera 39 - Polígono Industrial 'Las Monjas' 28850 Torrejón de Ardoz Madrid / Spain · Tel .: [phone] - FAX : [phone] Prepared October 8, 2008 Contact: Jose Maria Ortega, CEO

- 1. Identification of the Device: Proprietary-Trade Name: Suinsa Diagnostic X-Ray System (STATIONARY). Classification Name: Stationary X-ray system, Product Codes Product Code 90 KPR Common/Usual Name: General purpose diagnostic X-ray Unit.
- 2. Equivalent legally marketed devices: Almana Medical Radvision ET Diagnostic X-Ray Systems K082064
- 3. Indications for Use (intended use) This X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the 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.
- 4. Description of the Device: This system is a combination of the following Suinsa manufactured components:
- The Hercules Generator, with models from 32 to 80 kW. .
- The NOVA Ceiling Mounted Tube Stand .
- . The NET4000 series X-ray table
- The NBS2100 Bucky Wall Stand .
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench and standards testing indicates that the new device is as safe and effective as the predicate devices.

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### 6. Substantial Equivalence Chart

| Characteristic | Almana Medical Radvision ET | Suinsa Diagnostic X-Ray |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| | Diagnostic X-Ray Systems K082064 | System |
| Intended Use: | Intended for use by a qualified/trained doctor<br>or technician on both adult and pediatric<br>subjects for taking diagnostic radiographic<br>exposures of the skull, spinal column, chest,<br>abdomen, extremities, and other body parts.<br>Applications can be performed with the<br>patient sitting, standing, or lying in the prone<br>or supine position. | SAME |
| Configuration | Ceiling Mount (made by Suinsa) | SAME |
| Generator | High Frequency Sedecal | High Frequency Suinsa |
| Maximum output | Various models, 32 to 80 kW | SAME, 32 to 80 kW |
| Image Acquisition | Film | Film |
| Collimator | RALCO | SAME |
| Safety | UL Listed | CSA listed to US Standards |
| Standards | US Performance Standard + applicable IEC<br>standards | SAME |

#### 7. Conclusion

After analyzing bench and standards testing data, it is the conclusion of Suinsa that the Suinsa Diagnostic X-Ray Systems is as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The words "DEPARTMENT OF HEALTH HUMAN SERVICES - USA" are arranged in a circle around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 0 4 2008

Suinsa % Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015

Re: K083109

Trade/Device Name: Suinsa Diagnostic X-Ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 15, 2008 Received: October 21, 2008

## Dear Mr. Kamm:

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, Orve 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.

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#### Page 2

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 (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.

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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

loque Mr. Whang

Joyce M. Whang, Ph.D. Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):_ K08 3 | OS

Device Name: Suinsa Diagnostic X-Ray System

Indications For Use:

The Suinsa Diagnostic X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the 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)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dales Lemen

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