DDRFORMULA AND DDRFORMULA PLUS

K052943 · Swissray Medical AG · KPR · Dec 15, 2005 · Radiology

Device Facts

• Record ID: K052943
• Device Name: DDRFORMULA AND DDRFORMULA PLUS
• Applicant: Swissray Medical AG
• Product Code: KPR · Radiology
• Decision Date: Dec 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Swissray Medical AG direct digital X-ray Radiography diagnostic system (stationary) ddRFormula is a further development of the Addon Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRFormula is configured with a flat panel (a-Si) X-ray detector (FP5000) and is intended for general radiographic examinations of patients in a supine, seated or standing position. The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.

Device Story

The ddRFormula is a stationary direct digital X-ray radiography system; utilizes a flat panel (a-Si) X-ray detector (FP5000) to capture radiographic images. System operates in hospital or doctor practice X-ray rooms; used by trained radiologic technologists or physicians. Input consists of X-ray radiation passing through the patient; system transforms this into digital image data. Output is displayed on a high-resolution viewing station, sent to a film printer, or archived in a PACS system. Device facilitates diagnostic imaging for general radiography; assists clinicians in visualizing internal anatomy for diagnostic decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stationary direct digital X-ray system; utilizes a-Si (amorphous silicon) flat panel detector (FP5000); supports supine, seated, and standing patient positioning; output compatible with high-resolution viewing stations, film printers, and PACS via digital connectivity.

Indications for Use

Indicated for general radiographic examinations of patients in supine, seated, or standing positions in hospital or clinical settings.

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

• Addon Multi System

Submission Summary (Full Text)

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

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

DEC 15 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Swissray Medical AG % Mr. John Monahan Manager Swissray America Int., Inc. 1180 McLester Street, Unit #2 ELIZABETH NJ 07201

Re: K052943 Trade/Device Name: ddRFormula Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 18, 2005 Received: October 20, 2005

Dear Mr. Monahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced in we have reviewed your Section 910(ts) premaintent (for the indications for use stated in
above and have determined the device is substantially equivalent (for the stated in above and have determined the devices marketed in interstate commerce prior to the enclosure) to regally marketed predical Device Amendments, or to devices that have been May 28, 1978, the ellacinem date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the provisions of the coon (PMA). You may, therefore, market the A do not require approval of a promations of the Act. The general controls provisions of the Act. device, subject to the general controls provisions of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If vour device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classince (see above) income in the major regulations affecting your Approval), it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Parts 800 lo 8 device can be found in the coucerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised mat 1 DA s issualled of a subscribing with other requirements of the Act or any FDA has made a delemination mar your de Her Federal agencies. You must comply with all the Federal statues and regulations administered of Caristration and listing (21 CFR Part 807); labeling Act s requirements, metuding, but not mintee to reguirements as set forth in the quality systems (QS) (21 CFN 1 art 801); good manationing practically the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

This letter will allow you to begin marketing your device as described in your Section 510(k)
. The first and the collection of a location and equivalence of your device to a This letter will allow you to begin harketing your antial equivalence of your device to a legally.
premarket notification. The FDA finding of substantial equivalers and thus, premarket notification. The FDA Inding of Substantial of 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 Cirit Part 801), please If you desire specific advice for your device on our laboring 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 Also, please note the regulation entitled, "forsonation on your responsibilities under the Act from the 807.97). You may obtain other general information on your 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,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Image /page/2/Picture/1 description: The image shows the logo for Swissray, a company that specializes in direct digital X-ray technology. The logo features the word "Swissray" in a modern, sans-serif font, with the "y" extending downwards. To the right of the wordmark is a graphic element composed of several small squares arranged in a cluster, giving the impression of digital pixels. Below the wordmark, the tagline "FIRST IN DIRECT DIGITAL X-RAY" is printed in smaller, uppercase letters.

## 510 (K) Number K052943

Device name: ddRFormula

## Indication for Use

The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II
n Childer Childer AG direct digition AddQn Multi System The Swissray Medical AG direct digital A further development of the Addon Multi System.
(stationary) ddRFormula is a further development of the Addon Multi System. (Stationary) duril ormalia is a farther a or doctor practice X-ray room.
This system can be used in a hospital or doctor practice of the success a

This system can be used in a nospital of doctor practical rey detector (FP5000) and is The ddRFormula is comigured with a fiet panel (a Ch) A ray a stocked in a supine, seated or standing position.

standing position.
The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.

(Please do not write below this line- continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (DOE)

Prescription Use or Over-The Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

David C. Doggett

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