MOBILEDIAGNOST WDR

K111725 · Sedecal., Sa. · IZL · Jul 19, 2011 · Radiology

Device Facts

• Record ID: K111725
• Device Name: MOBILEDIAGNOST WDR
• Applicant: Sedecal., Sa.
• Product Code: IZL · Radiology
• Decision Date: Jul 19, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

Device Story

MobileDiagnost wDR is a mobile digital radiography system combining a motor-driven mobile x-ray generator with a wireless portable digital detector. Input consists of x-ray radiation passing through the patient; the detector captures the signal and transmits it to a radiographic workstation. The system produces digital diagnostic images for clinical review. Used in clinical settings (e.g., hospital wards, OR) by physicians or technologists. The output allows clinicians to visualize internal anatomy for diagnostic decision-making, facilitating rapid patient assessment in mobile environments. The device integrates a Sedecal high-frequency generator and a Philips Wireless Portable Detector (FD-W17).

Clinical Evidence

Bench testing and clinical image comparison performed. Clinical images acquired with the device were compared to images from predicate devices; no significant differences were observed. Software validation and safety testing (conforming to US Performance Standards and CSA certification) were completed. No clinical trial data provided.

Technological Characteristics

Mobile x-ray system; high-frequency generator (20-50 kW); wireless digital flat panel detector (35x43 cm, 144 um pixel size, 3.5 LP/mm resolution). Connectivity via wireless or backup cable to docking station/workstation. Electrical safety per IEC-60601; UL listed. Complies with 21 CFR 1020.30.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic exposures of the skull, spine, chest, abdomen, and extremities. Can be used with patients sitting, standing, or lying (prone/supine). Contraindicated for mammography.

Regulatory Classification

Identification

A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Easy Moving Plus, Mobile Diagnostic X-Ray (K090322)
• Wireless Portable Detector FD-W17 (K090625)

Reference Devices

• Digital CANON CDXI-50G (K031447)

Submission Summary (Full Text)

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### 510(K) Summary, Special 510(k) K11

| Page 1 of 2<br>Submitters: | | K111729 |
|----------------------------------|----------------------------------------------|---------|
| PHILIPS Medical Systems DMC GmbH | SEDECAL SA | |
| Roentgenstrasse 24 | Pelaya 9- Poligono Industrial Rio De Janeiro | |
| 22335 Hamburg | 28110 - Algete | |
| Germany | Madrid Spain | |
| Tel. [phone] - 0 | Tel [phone] | |
| Fax: [phone] - 2002 | Fax [phone] | |

Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager, Sedecal SA Date Prepared: June 10, 2011

#### Identification of the Device: 1.

Proprietary-Trade Name: MobileDiagnost wDR Classification Name: System, x-ray, mobile, IZL and solid state x-ray imager (flat panel/digital imager), MQB Common/Usual Name: Mobile Diagnostic X-ray System with Digital Panel

#### Equivalent legally marketed devices: 2.

- Easy Moving Plus, Mobile Diagnostic X-Ray (K090322) marketed by Sedecal .
- The Detector is identical to the Wireless Portable Detector FD-W17 (K090625) marketed by . Philips Medical Systems
- 3. Description of the Device: This device is simply the combination of two cleared devices, the Wireless Portable Detector FD-W17 (K090625) marketed by Philips Medical Systems and the Easy Moving Plus, Mobile Diagnostic X-Ray (K090322) made by Sedecal. The x-ray source is a motor driven mobile x-ray and the x-ray receptor panel is a digital wireless unit. The Wireless Portable Detector FD-W17 consists of three main parts:
- · Portable radiography detector (x-ray sensitive part)
- · docking station which is directly connected to the radiographic workstation
- · backup cable which can connect the detector to the docking station if the wireless connection cannot be used.

Detector size: 35 x 43 cm (14 x 17") Image matrix size: 3000 pixels x 2400 pixels. Pixel size 144 um、Image resolution up to 3.5 LP/mm

- 4. Indications for Use (intended use): Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
- 5. Safety and Effectiveness, comparison to predicate device. This modified device has the same indications for use and technological characteristics as the predicate devices, in fact employing the predicate devices in the end product.
- Description of Testing: Clinical images were acquired and compared to our predicate images. 6. There were no significant differences between them. We also performed software validation testing. The results of clinical, bench, safety test, and software validation testing indicates that the new device is as safe and effective as our predicate device. The modified device conforms to US Performance Standards and the hardware is CSA Certified compliant to US Standards for safety for medical devices.

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### 510(k) Summary K11 Page 2 of 2

| Characteristic | Sedecal Easy Moving Digital<br>K090322 | MobileDiagnost wDR |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Intended Use: | Intended for use by a<br>qualified/trained doctor or<br>technician on both adult and<br>pediatric subjects for taking<br>diagnostic radiographic exposures<br>of the skull, spinal column, chest,<br>abdomen, extremities, and other<br>body parts. Applications can be<br>performed with the patient sitting;<br>standing, or lying in the prone or<br>supine position. (Not for<br>mammography) | SAME |
| Configuration | Battery or line operated mobile | SAME |
| Performance Standard | 21 CFR 1020.30 | SAME |
| Generator | High frequency made by Sedecal | SAME |
| Generator power levels | 20 to 50 kw (4 models) | 20 to 50 kw (4 models) |
| Collimator | Ralco R221 DHHS | Ralco 108F DHHS<br>-equivalent |
| Image acquisition | Digital CANON CDXI-50G<br>K031447 | Philips Wireless Portable Detector<br>FD-W17 K090625 |
| Electrical safety | Electrical Safety per IEC-60601.<br>UL listed | SAME |

## 7. Substantial Equivalence Chart

- Conclusion: After analyzing risk analysis, software validation, safety testing data, and clinical 8. images, it is the conclusion of Sedecal that the MobileDiagnost wDR is as safe and effective as the predicate devices, have almost no technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate devices.
:

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus, indicating the department's name and affiliation with the United States of America.

Public Health Service

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

Sedecal SA % Ms. Jennifer Cartledge VP Product Development and Program Management REU Associates, Inc. 409 Woodridge Dr SENECA SC 29672

Re: K111725

Trade/Device Name: MobileDiagnost wDR Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL and MQB Dated: June 16, 2011 Received: June 20, 2011

JUL 1 9 2011

Dear Ms. Cartledge:

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 aboye) 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 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 number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary S Patel

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

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# Indications for Use

510(k) Number (if known): K11

Device Name: MobileDiagnost wDR

Indications For Use:

Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

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 In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostis

Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Library Leagues Li

510K K111725

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