(12 days)
Not Found
No
The summary describes a digital X-ray detector and its intended use, but there is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No.
The device is indicated for generating radiographic images for diagnostic purposes, not for treating conditions.
Yes
The device is described as being used in "general purpose diagnostic procedures" to generate "radiographic images," which are used for diagnosis.
No
The device description explicitly states it is a "digital X-Ray detector comprised of amorphous silicon with a cesium iodide scintillator," which are hardware components.
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 GE Tethered Portable Digital Radiographic Detector is used to generate radiographic images of human anatomy using X-rays. This is an in vivo imaging technique, meaning it is performed on the living body, not on samples taken from the body.
- Intended Use: The intended use clearly states it's for generating radiographic images of human anatomy and replacing film/screen systems in general purpose diagnostic procedures. This aligns with medical imaging, not in vitro testing.
Therefore, the device's function and intended use fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The GE Tethered Portable Digital Radiographic Detector 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 mammograpohic applications.
Product codes
90 IZL
Device Description
The GE Tethered Portable Digital Radiographic Detector is a digital X-Ray detector comprised of amorphous silicon with a cesium iodide scintillator that has been repackaged for mobile and portable use, and may be used as a film cassette replacement in portable radioraly unis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards.
Clinical Tests: None required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
1204/1922
JUL 28 2004
Special 510(k) Premarket Notification GE Medical Systems - Tethered Portable Digital Radiographic Detector July 14, 2004
Attachment B:
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
GE Medical Systems
General Electric Company P.O. Box 414, Milwaukee, WI 53201
| Submitter: | GE Medical Systems
PO Box 414
Milwaukee, WI 53201 |
|------------------|-----------------------------------------------------------------------------------------------------|
| Contact Person: | D. Duersteler
Safety and Regulatory Engineering
Telephone: 262-312-7029; Fax: 262-312-7144 |
| Date Prepared: | July 14, 2004 |
| Device Name: | GE Tethered Portable Digital Radiographic Detector.
Mobile X-ray System, 21 CFR 892.1720, 90 IZL |
| Marketed Device: | GE Digital Radiographic Imaging System |
gital Radiographic Imaging System, 510(k) Number K982196, currently in Marketed Device: commercial distribution.
Device Description: The GE Tethered Portable Digital Radiographic Detector is a digital X-Ray detector comprised of amorphous silicon with a cesium iodide scintillator that has been repackaged for mobile and portable use, and may be used as a film cassette replacement in portable radioraly unis.
Indications for Use: The GE Tethered Portable Digital Radiographic Detector is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/ose in systems in all general purpose diagnostic procedures. This device is not intended for mammograpohic applications.
Comparison with Predicate Device: The GE Tethered Portable Digital Radiographic Detector is of a comparable type and substantially equivalent to the currently marketed GE Digital Radiographic Inaging System. It has the same X-ray detection technology, the same technological characteristics, the same materials, and is comparable in key safety and effectiveness features. It uses the same basic design and construction except it has been made more rugged, and the weight and power crequirements trave been reduced. It has the same intended uses as the predicate device.
Summary of Studies: The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards.
Clinical Tests: None required.
്രാമ്പ്യച്ചാത്രം Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Intended uses and fundamental scientific technology are the same as the legally marketed GE Digital Radiographic Imaging System. The design and development process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with factory suncer standards and Collpliance is Systems that the GE Tethered Portable Digital Radiographic Detector is substantially equivalent with respect to safety and effectiveness to devices currently cleared for macket.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 8 2004
Mr. David Duersteler Safety and Regulatory Engineering General Electric Company GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201
Re: K041922
Trade/Device Name: GE Tethered Portable Digital Radiographic Detector Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: 90 IZL Dated: July 14, 2004 Received: July 16, 2004
Dear Mr. Duersteler:
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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,
2
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Special 510(k) Premarket Notification GE Medical Systems - Tethered Portable Digital Radiographic Detector July 14, 2004
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K041922
Device Name: GE Tethered Portable Digital Radiographic Detector
Indications for Use
The GE Tethered Portable Digital Radiographic Detector 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 mammograpohic 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
David A. Lyman
(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number