(106 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard radiographic components and image processing capabilities.
No.
The device is a diagnostic imaging system used to generate radiographic images, not to treat or cure a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to replace radiographic film/screen systems in all general purpose diagnostic procedures."
No
The device description explicitly lists multiple hardware components including a detector, wallstand, tubestand, x-ray tube, collimator, system controller, and generator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Digital Radiographic Imaging System is used for "generating radiographic images of human anatomy." This involves using X-rays to create images of internal structures within the body, not analyzing samples taken from the body.
- Intended Use: The intended use is to "replace radiographic film/screen systems in all general purpose diagnostic procedures," which are imaging procedures, not laboratory tests.
Therefore, this device falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Product codes (comma separated list FDA assigned to the subject device)
KPR, MQB
Device Description
The Digital Radiographic Imaging System is designed to perform radiographic examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing and storage. The Digital Radiographic Imaging System consists of a wallstand, tubestand, x-ray tube, collimator, system controller, generator and digital detector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Two radiologists at each of three hospitals evaluated 30 paired digital and film / screen images of representative anatomical areas, and found that the digital images had equivalent or better image quality.
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.
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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular shape. The letters and the circle are filled with a dark color, contrasting with the white background. The logo is positioned to the right side of the image.
OCT
e lass
GE Medical Systems
General Linten Company P ( Box 11: Aldy Juker: 31: 3 . 81-9412
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Pat 807.87(h).
| Identification of Submitter: | Larry A. Kroger, Ph.D.
Senior Regulatory Programs Manager
GE Medical Systems
Tel. (414) 544-3894
Summary prepared: 19 June, 1998 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of Product: | Digital Radiographic Imaging System |
Stationary X-ray System Classification Name: Manufacturer: GE Medical Systems 3000 N. Grandview Blvd. Waukesha, WI 53188
Marketed Devices: The SG60 vertical wallstand was pre-Amendment and the SCX radiographic system was introduced in 1986 (K862120). Subsequently, these were used with the Ultranet-SA Collimator (K894142), the Maxiray 100 Radiographic Tube (K812915), and the SCPU Generator (K940277).
- Device Description: The Digital Radiographic Imaging System is designed to perform radiographic examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing and storage. The Digital Radiographic Imaging System consists of a wallstand, tubestand, x-ray tube, collimator, system controller, generator and digital detector.
- Indications for Use: The Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film / screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
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Comparison with It is the opinion of GE Medical Systems that the Digital Predicate: Radiographic Imaging System is of comparable type and substantially equivalent to the Advantx Radiographic System (originally cleared as the SCX K862120) combined with a SG-60 vertical wallstand with respect to intended use, radiation characteristics and image quality. The Digital Radiographic Imaging System presents no new safety concerns. It will comply with the x-ray requirements of 21CFR as well as safety requirements of UL2601-1, IEC601-1 and collateral standards. Summary of Studies: Two radiologists at each of three hospitals evaluated 30 paired digital and film / screen images of representative anatomical
Conclusions: GE considers the Digital Radiographic Imaging System to be equivalent with the predicate device. Digital Radiographic Imaging System provides radiograms that result in equivalent or better imaging performance than film / screen images. The potential hazards, e.g., wrong measurements and misdiagnosis, are controlled by a risk management plan including:
-
· A Hazard Analysis
image quality. -
· A Software Development and Validation Process
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· External validations of paired sets of film / screen image and digital images by three different research hospitals to assess the diagnostic equivalence of the digital images.
areas, and found that the digital images had equivalent or better
:
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services. The logo includes the department's seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The text is in a sans-serif font and is blue.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager General Electric Company PO Box 414 MILWAUKEE WI 53201
AUG 20 2013
Re: K982196
Trade/Device Name: GE Digital Radiographic Imaging System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MQB Dated: September 4. 1998 Received: September 8, 1998
Dear Dr. Kroger:
This letter corrects our substantially equivalent letter of October 6. 1998.
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 (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 (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
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STATEMENT OF INTENDED USE
510(k) Number (if known):
510(k) Number (if known): K982/960
Device Name: Digital Radiographic Imaging System
Indications for Use
The Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801-109)
OR Over-The-Counter Use_
OR Over-The-Counter Use_
Eirid a. Sijmm
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devi 510(k) Number
なくなる。
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