(18 days)
No
The summary describes a standard digital X-ray system with image post-processing capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an X-ray system intended for taking diagnostic radiographic exposures, which means it is used for imaging and diagnosis, not for treating diseases or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the X-Ray Systems are intended "for taking diagnostic radiographic exposures." The device is designed to produce images that are used by doctors or technicians to diagnose conditions.
No
The device description explicitly lists hardware components such as an elevating or non-elevating table, a floor column stand with rotating U-arm, a Digital Detector, and an X-ray generator/power unit. While it includes software for image processing and review, it is part of a larger hardware system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Definium™ 5000 X-Ray System is used to take radiographic images of the internal structures of the body directly on the patient. It does not analyze samples taken from the patient.
- Intended Use: The intended use clearly states it's for taking diagnostic radiographic exposures of various body parts on live subjects.
Therefore, based on the provided information, the Definium™ 5000 X-Ray System is a radiological imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Definium™ 5000 X-Ray Systems 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)
KPR, MOB
Device Description
The Definium 5000 Digital Radiographic Imaging System provides state of the art image quality, image manipulation, operator control, dose reporting and system maintenance. These features make this system easy to use and reliable while providing high quality radiographic images in a digital environment. The Definium 5000 System is designed to handle radiographic applications using the digital table. The system configuration includes an elevating or non-clevating table, a floor column stand with rotating U-arm, and GE's patented Digital Detector that captures radiographic images in digital form, as well as an X-ray generator/power unit. An Acquisition and Review Workstation for image post-processing, short-term storage, and quick in-room viewing of images is included as part of the system. Images may be transferred manually or automatically via a DICOM network for printing, longterm storage archive, and detailed review.
Mentions image processing
Yes
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.
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
K063283
EXHIBIT 2 510(k) Summarv
NOW 1 7 2006
| 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) |
GE Medical Systems, LLC 3200 N. Grandview Blvd. Waukesha, WI 53188 Phone: 262-544-3012 Fax: 262-544-3863 (Digital Panel Manufacturer Contact: Ms. Martha Kamrow
September 18, 2006
-
- Identification of the Device: Proprietary-Trade Name: Definium™ 5000 X-Ray System Classification Name: Stationary X-ray system, Product Codes Product Code 90 KPR and MOB Common/Usual Name: Gencral purpose diagnostic X-ray Unit.
-
- Equivalent legally marketed devices: This notification is for a MODIFIED device COMBINES two 510(k) cleared devices, the SEDECAL X PIJJS LP PLUS Universal Radiographic Systems K062335 AND the GE Medical Systems Digital Radiographic Detector, K041922. This combination is functionally identical to a SEDECA1. cleared device, Sedccal URS LP X-Ray Units with Digital Detector, K042876.
-
- Indications for Use (intended usc) The Definium™ 5000 X-Ray Systems 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: The Definium 5000 Digital Radiographic Imaging System provides state of the art image quality, image manipulation, operator control, dose reporting and system maintenance. These features make this system easy to use and reliable while providing high quality radiographic images in a digital environment. The Definium 5000 System is designed to handle radiographic applications using the digital table. The system configuration includes an elevating or non-clevating table, a floor column stand with rotating U-arm, and GE's patented Digital Detector that captures radiographic images in digital form, as well as an X-ray generator/power unit. An Acquisition and Review Workstation for image post-processing, short-term storage, and quick in-room viewing of images is included as part of the system. Images may be transferred manually or automatically via a DICOM network for printing, longterm storage archive, and detailed review.
-
- 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 Definium™ 5000 X-Ray
| Characteristic | Sedecal URS X-
Ray Units with
Digital Detector
K042876 | SEDECAL X
PLUS LP PLUS
Universal
Radiographic
Systems K062335 | Definium™ 5000
(This Submission):
Combines two
cleared devices:
K062335 AND
K041922 |
|--------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Intended Use: | General purpose
diagnostic X-ray unit | SAME | SAME |
| User Interface | Depends on Control
Console option
chosen. Mainly
dedicated touch
controls | Software Driven
Touch Panel LCD, +
IR remote control unit | Software Driven
Touch Panel LCD. +
remote control unit +
remote console |
| Maximum output | Depends on model of
generator chosen.
Models available from
30 kW 10 64 kW | SAME as original
units. | 64 Kw model only. |
| Image Acquisition | Digital: CANON
CXDI-50G.
K031447 | Film | Digital: GE Tethered
Portable Digital
Radiographic Detector
K041922 |
| Digital Panel Size | Up to 14" x 17" active
area | N/A | 16" x 16" active area |
| Digital Resolution | 160 x 160 microns
pixel pitch, with
approximately 6
million pixels | N/A | 200 x 200 micron
pixel pitch,
approximately 4
million pixels. |
| Method of Control | Dedicated push button
Controls | Software Driven
Touch Panel LCD.
+IR remote control
unit | Software Driven
Touch Panel LCD.
+IR remote control
unit and control room
interface box. |
| Collimator | Manual R302/A | Manual R302/A and
Automatic available | Automatic Collimator
Hewitt 150 |
7. Conclusion
After analyzing bench, user, and standards testing data, it is the conclusion of Scdccal that the Definium™ 5000 Radiographic System with Digital Detector is as safe and effective as the procate devices, have few technological differences, and have no new indications for use, thus rendering then substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image contains a circular logo on the left and some text on the right. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around a symbol that resembles an abstract eagle or bird. The text on the right is not clear enough to read.
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 % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015
AUG 23 2013
Re: K063283
Trade/Device Name: Definium™ 5000 X-Ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB and KPR Dated: October 30, 2006 Received: October 30, 2006
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of November 17, 2006.
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. Iisting 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 (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
Janine M. Morr 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): _ | 0632 8 3
Device Name: Definium™ 5000 X-Ray System
Indications For Use:
Indications for Use: The Definium™ 5000 X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic rapisures of the skull, spinal column, chest, abdomen, cxtremities, and other hody 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 Clik 807 Subpart C)
(17 JEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Maureen C. Brandon
Page 1 of 1
(Division Sign-Off)0.
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K062883
Page 8 of 504