PRECISION 500D R&F X-RAY SYSTEM

K081091 · GE Healthcare · JAA · Jun 11, 2008 · Radiology

Device Facts

• Record ID: K081091
• Device Name: PRECISION 500D R&F X-RAY SYSTEM
• Applicant: GE Healthcare
• Product Code: JAA · Radiology
• Decision Date: Jun 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

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 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

Device Story

Precision 500D R&F X-ray System is a universal diagnostic imaging system for radiographic and fluoroscopic examinations. System components include X-ray generator, angulating table, X-ray tube, collimator, image intensifier, wall stand, overhead tube suspension, operator console, and digital archive system. Operated by physicians or technicians in clinical settings to capture diagnostic images of adult and pediatric patients. Device utilizes high-voltage 3-phase 80kW generator (Jedi 80TF2T) to produce X-ray exposures. Output images are viewed by healthcare providers to support clinical decision-making and diagnosis. Pediatric Grid-in mode provides dose reduction compared to adult modes while maintaining image quality (SNR).

Clinical Evidence

Bench testing only. Verification demonstrated minimum 35% dose reduction in Pediatric Grid-in mode (at 7.5 fps and 30 fps) compared to Adult Grid-in mode (at 30 fps) using 32cm or 40cm Image Intensifiers. Image quality maintained with maximum SNR difference of 15%.

Technological Characteristics

System includes X-ray generator, angulating table, tube, collimator, image intensifier, wall stand, and digital archive. Energy source: High Voltage Generator 3 Phase 80kW (Model Jedi 80TF2T). No patient-contact materials requiring biocompatibility. Connectivity: Digital archive system.

Indications for Use

Indicated for diagnostic radiographic and fluoroscopic imaging of the whole body (skull, spine, chest, abdomen, extremities) in adult and pediatric patients. Used by qualified clinicians/technicians with patients in sitting, standing, prone, or supine positions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Precision 500D R&F X-ray System (K011624)

Submission Summary (Full Text)

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K081091/

# 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 [e-mail] 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/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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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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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 [phone] or [phone] 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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