(31 days)
Not Found
No
The summary describes a standard X-ray unit and detector combination with a common user interface, and there is no mention of AI, ML, or advanced image processing beyond basic X-ray acquisition.
No
The device is described as taking "diagnostic radiographic exposures," which means it is used for diagnosis, not treatment (therapy).
Yes
The device is described as taking "diagnostic radiographic exposures," directly indicating its role in forming a diagnosis.
No
The device description clearly states it is a stationery X-ray unit with hardware components like high frequency inverters and a color LCD touch panel, and it combines two FDA cleared hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use of this device is to take diagnostic radiographic exposures of various body parts directly on the patient.
- The device description and intended use clearly indicate it's an X-ray imaging system. X-ray systems are used for in-vivo imaging (imaging within the living body), not for analyzing samples outside the body.
- There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD testing.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Sedecal URS LP/Millennium/RadPro Xray Units with Detector are 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.
Product codes (comma separated list FDA assigned to the subject device)
90 KPR, MQB
Device Description
URS LP/Millennium/RadPro X-ray Units with Detector are stationery units which operate from 120 or 220 V 50-60~ AC. The units utilize high frequency inverters. The usual safety precautions regarding the use of x-rays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G. The new units offer additional mounting options for the tube head and other components.
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 subjects
Intended User / Care Setting
qualified/trained doctor or technician
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices.
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
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.
0
EXHIBIT 2 510(k) Summary
| SEDECAL SA --
Pelaya 9- Poligono Industrial Rio De
Janeiro
28110-Algete
Madrid Spain
Tel (34) 91-628 0544/91-628 1592
Fax (34) 91-628 0574
(Foreign Manufacturer) | SEDECAL USA, Inc.
2910 N. Arlington Heights Rd.
Arlington Heights Illinois 60006
Tel 847-394-6960
Fax 847-394-6966
(Initial Importer)
Contact: Devan Moser |
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
October 13, 2004
-
- Identification of the Device: Proprietary-Trade Name: URS LP/Millennium/RadPro X-ray Units with Detector Classification Name: Mobile X-ray system, Product Codes Product Code 90 KPR and MQB Common/Usual Name: General purpose diagnostic X-ray Unit.
-
- Indications for Use (intended use) The Sedecal URS LP/Millennium/RadPro Xray Units with Detector are 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.
-
- Description of the Device: URS LP/Millennium/RadPro X-ray Units with Detector are stationery units which operate from 120 or 220 V 50-60~ AC. The units utilize high frequency inverters. The usual safety precautions regarding the use of x-rays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G. The new units offer additional mounting options for the tube head and other components.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices.
1
- Substantial Equivalence Chart, The Sedecal Portable X-ray Units with Detector
| Characteristic | Sedecal URS
K012546 | Canon CXDI-50G
Digital
Radiography,
K031447 | URS LP/
Millennium/
RadPro X-ray Units
with Detector
(Combination
device) |
|----------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Intended Use: | General purpose
diagnostic X-ray unit | SAME | SAME |
| Energy Source: | 120V,
230/240V(50/60Hz)
Line or Battery Power | 100V, 120V,
230/240V(50/60Hz) | SAME (Combined
device) |
| User Interface | Depends on Control
Console option
chosen. Mainly
dedicated touch
controls | Software Driven
Touch Panel LCD | Software Driven
Touch Panel LCD |
| Maximum output | Depends on model of
generator chosen.
Models available from
30 kW to 64 kW | N/A | SAME as original
units. |
| Tube mount | Fixed with respect to
receptor, arm can
rotate. | | Additional mounting
options:
Column mount, and
ceiling mount options
now available. |
| Receptor mount | Fixed on same
column as tube head | N/A | Wall mount and table
mount now available |
| Digital Resolution | N/A | 160 x 160 microns
pixel pitch, with
approximately 6
million pixels and
4,096 gray scale
contrast | SAME (Combined
device) |
| Method of Control | Dedicated push button
Controls | Software Driven
Touch Panel LCD | Software Driven
Touch Panel LCD |
| Performance Standard | 21 CFR 1020.30 | SAME | SAME |
| Electrical safety: | UL 2601,
IEC 60601-1 | SAME | SAME |
7. Conclusion
After analyzing bench, user, and standards testing data, it is the conclusion of Sedecal that the Sedecal Portable X-ray Units with Detector are 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.
2
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
SEDECAL SA % Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015
AUG 20 2013
Re: K042876
Trade/Device Name: URS LP/Millennium/RadPro X-Ray Units with Digital Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: October 13, 2004 Received: October 19, 2004
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of November 18, 2004.
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 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,
Janine M. Morris
Acting 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):_
Device Name: URS LP/Millennium/RadPro X-Ray Units with Digital Detector
Indications For Use:
Indications for Use: The URS LP/Millennium/RadPro Radiographic Systems with Digital Detector are 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)
Nancy C. Brogdon
and Radiological Devic 510kl Nun
Page 1 of 1