(56 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or algorithms that would typically indicate the presence of AI/ML. The performance studies focus on dose reduction and SNR, which are standard metrics for X-ray systems and do not inherently involve AI/ML.
No
This device is described as a "universal diagnostic imaging system for radiographic and fluoroscopic examinations," indicating its purpose is to create images for diagnosis rather than to treat a condition.
Yes.
The "Intended Use" section explicitly states that the device is "intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations." It also mentions "taking diagnostic radiographic and fluoroscopic exposures."
No
The device description explicitly lists multiple hardware components (X-ray generator, angulating table, collimator, image intensifier, wall stand, overhead tube suspension, operator console, digital archive system) that are integral to the 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, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The Precision 500D R&F X-ray System is an imaging system that uses X-rays to create images of the inside of the body. This is an in vivo diagnostic method, meaning it is performed within the living body.
- Intended Use: The intended use clearly states it's for "diagnostic imaging system for radiographic and fluoroscopic examinations" of the body. This involves taking images directly from the patient.
- Device Description: The components listed (X-ray generator, table, collimator, image intensifier, etc.) are all typical of an X-ray imaging system, not a device for analyzing biological specimens.
Therefore, based on the provided information, the Precision 500D R&F X-ray System is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, 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
JAA
Device Description
The Precision 500D R&F X-ray System consists of an X-ray generator, angulating table with x-ray tube, collimator and image intensifier, wall stand, overhead tube suspension operator console and digital archive system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic x-ray, radiographic x-ray
Anatomical Site
whole body, 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)
Bench testing verification was performed and a complete testing summary can be found in Section 18. Verification supports a minimum of 35% less dose when measured with a 32cm Image Intensifier (II) or 40cm II system in Pediatric Grid-in mode at 7.5 frames per second (fps) as compared to Adult Grid-in Mode at 30fps while comparatively quantifying image quality with a maximum difference in Signal to Noise Ratio (SNR) of 15%. Additionally verification supports a minimum of 35% less dose when measured with a 32cm II or 40cm II system in Pediatric Grid-in mode at 30fps as compared to Adult Grid-in Mode at 30fps while comparatively quantifying image quality with a maximum difference in SNR of 15%. Dose savings represent a minimum specification, averaged over all magnification modes, and SNR calculations are performed with "Iodine" selected as contrast agent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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/21 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and there are three short, curved lines extending outward from the circle at different points.
GE Healthcare
510(k) Summary
JUN 1 1 2008
The following 510(k) Summary was prepared in accordance with the requirements of 21 CFR §807.87(h) and §807.92.
- (1) Identification of Submitter:
Submitter: Address: Contact Person: Telephone #: Summary Prepared:
GE Healthcare 3000 N. Grandview Blvd W-709 Michael Petrowski (262)-548-2673 02-01-2008
Alternate Contact:
- John L. Schmidt GE Healthcare Safety & Requlatory Enqineer T 262 548 4964 E John.L.Schmidt@med.ge.com 3000 N. Grandview Blvd. W709 Waukesha, WI, 53188-1678, USA
- (2) Device Information:
GE Model Name: Classification Name: Class: Product Code:
Precision 500D R&F X-ray System Image-intensified fluoroscopic x-ray system Class II JAA
- (3) Predicate Device:
510(k) Number: GE Model Name:
Product Code:
Classification Name:
K011624
Precision 500D R&F X-ray System (Previous Name: Expedio 500D R&F X-ray System) Image-intensified fluoroscopic x-ray system Class II JAA -
- (4) Device Description:
Class:
The Precision 500D R&F X-ray System consists of an X-ray generator, angulating table with x-ray tube, collimator and image intensifier, wall stand, overhead tube suspension operator console and digital archive system
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Image /page/1/Picture/0 description: The image shows the text "GE Healthcare". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "GE" on the left and "Healthcare" on the right. The text is black and the background is white.
Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters and the circle are black, while the background is white.
(5) Statement of Intended Use:
The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
The Precision 500D R&F X-ray Systems are intended for use by a auglified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, 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
- (6) Technological Characteristic Comparison:
Design:
Precision 500D R&F X-ray System is identical in design and technology to the previously cleared Precision 500D R&F X-ray System K011624. There are no changes to the design and/or technology.
Material:
Precision 500D R&F X-ray System uses the exact construction materials as used in the previously cleared Precision 500D R&F X-ray System K011624. There are no changes to the materials.
Chemical Composition:
Chemical composition of materials is not critical for this type of device, because no material is implanted or inserted into the patient body or orifice to contact body tissues or fluids. Patient contact is not required for proper functionina of the device. See Section 15 for a statement regarding patient support tabletop material.
Energy Source:
The Precision 500D R&F X-Ray System uses the same energy source as was used in the previously cleared Precision 500D R&F X-ray System K011624: High Voltage Generator 3 Phase 80kW, Model Jedi 80TF2T, 2290800
Non-clinical Testing:
Bench testing verification was performed and a complete testing summary can be found in Section 18. Verification supports a minimum of 35% less dose when measured with a 32cm Image Intensifier (II) or 40cm II system in Pediatric Grid-in mode at 7.5 frames per second (fps) as compared to Adult Grid-in Mode at 30fps while comparatively quantifying image quality with a maximum difference in Signal to Noise Ratio (SNR) of 15%. Additionally verification supports a minimum of 35% less dose when measured with a
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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. There are three small, stylized flourishes or dots placed around the circle, adding a decorative element to the design.
GE Healthcare
32cm II or 40cm II system in Pediatric Grid-in mode at 30fps as compared to Adult Grid-in Mode at 30fps while comparatively quantifying image quality with a maximum difference in SNR of 15%. Dose savings represent a minimum specification, averaged over all magnification modes, and SNR calculations are performed with "Iodine" selected as contrast agent.
Conclusion:
GE Healthcare considers the Precision 500D R&F X-ray System to be substantially equivalent to the identified predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 2008
Mr. Michael Petrowski Safety & Regulatory Engineer GE Medical Systems 3000 N. Grandview Blvd. WAUKESHA WI 53188
Re: K081091
Trade/Device Name: Precision 500D R&F X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: February 1, 2008 Received: April 16, 2008
Dear Mr. Petrowski:
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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device i 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.
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Page 2
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C. Burgdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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GE Healthcare
Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular frame. The letters and the frame are solid black, creating a strong contrast against the white background.
Indication for Use
510(k) Number (if known): K081091
Device Name: Precision 500D R&F X-ray System
Indication For Use:
The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, 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 (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510k)
(Divisio h Sian-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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