(29 days)
Not Found
No
The device description focuses on the hardware components and their combination, and there is no mention of AI, ML, or advanced image processing techniques. The performance studies compare clinical images to predicate images, which is typical for demonstrating equivalence of a standard imaging device.
No
The device is described as an X-ray system used for taking diagnostic radiographic exposures, which means it aids in diagnosis rather than providing therapy. Its intended use explicitly states "taking diagnostic radiographic exposures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for taking diagnostic radiographic exposures." This indicates its role in the diagnostic process.
No
The device description explicitly states it is a combination of two cleared hardware devices: a mobile diagnostic X-ray machine and a wireless portable detector. It describes physical components like the detector size, image matrix, and pixel size, indicating it is a hardware-based system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device is an X-ray system used to image the internal structures of the body directly.
- The intended use and device description clearly state it's for taking radiographic exposures of various body parts. This is a form of in vivo imaging, not in vitro testing.
- There is no mention of analyzing biological samples or performing tests on specimens.
This device falls under the category of medical imaging devices, specifically an X-ray system.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
IZL, MQB
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts.
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
qualified/trained doctor or technologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical images were acquired and compared to our predicate images. There were no significant differences between them. We also performed software validation testing.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical, bench, safety test, and software validation testing indicates that the new device is as safe and effective as our predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1720 Mobile x-ray system.
(a)
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.(b)
Classification. Class II.
0
510(K) Summary, Special 510(k) K11
| Page 1 of 2
| 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. +49-040 2899 - 0 | Tel +34- 91-628 0544/91-628 1592 | |
| Fax: +49-040 2899 - 2002 | Fax +34- 91-628 0574 |
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
-
- 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
-
- 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.
-
- 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.
1
510(k) Summary K11 Page 2 of 2
| Characteristic | Sedecal Easy Moving Digital
K090322 | MobileDiagnost wDR |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Intended Use: | 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. (Not for
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
-equivalent |
| Image acquisition | Digital CANON CDXI-50G
K031447 | Philips Wireless Portable Detector
FD-W17 K090625 |
| Electrical safety | Electrical Safety per IEC-60601.
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.
:
2
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
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(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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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
4
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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