MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR

K052884 · Toshiba America Medical Systems, In.C · OWB · Oct 26, 2005 · Radiology

Device Facts

• Record ID: K052884
• Device Name: MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: OWB · Radiology
• Decision Date: Oct 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

This device is a digital radiography system used in diagnostic X-ray angiography system configuration. This X-ray angiography system is indicated for use in diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower limb blood vessels. It is intended to replace images obtained through the image intensifier technology.

Device Story

Digital radiography system for diagnostic X-ray angiography; utilizes Flat Panel Detector (FPD) to capture X-ray signals; replaces traditional image intensifier technology; processes, displays, and records digital images; used in clinical settings for diagnostic and interventional vascular procedures; operated by trained medical professionals; provides real-time or recorded visualization of blood vessels to guide clinical decision-making and improve diagnostic accuracy.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological comparison and bench testing.

Technological Characteristics

Digital radiography system; Flat Panel Detector (FPD) technology; replaces image intensifier; diagnostic X-ray angiography configuration.

Indications for Use

Indicated for diagnostic and interventional procedures of cardiac, cerebral, abdominal, and lower limb blood vessels.

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

• DFP-8000D with Image Intensifier (K013608)

Submission Summary (Full Text)

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K052884

OCT & 6 2009

# 510(k) SUMMARY

| 1. DEVICE NAME: | Solid State X-Ray Imager |
|-------------------------|-----------------------------------------------------------|
| Model Name: | DFP-8000D / FPD |
| Trade/Proprietary Name: | Digital Radiography System with Flat Panel Detector (FPD) |

- 2. ESTABLISHMENT REGISTRATION: 2020563
3. U.S. Agent Name and Address: TOSHIBA AMERICA MEDICAL SYSTEMS,INC. 2441 MICHELLE DRIVE TUSTIN, CA 92780 Contact Person: Michaela Mahl Senior Regulatory Affairs Specialist (714) 730 - 5000 Manufacturing Site: 4. TOSHIBA MEDICAL SYSTEMS CORPORATION 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan 5. Date of Submission: October 05, 2005

- 6. Predicate Device: DFP-8000D with Image Intensifier (K013608)
#### 7. DEVICE DESCRIPTION

This equipment is a digital radiography with Flat Panel Detector (FPD) used in diagnostic X-ray angiography system configuration.

This equipment processes, displays, and records digital images obtained from the Fiat Panel Detector, and it replays the recorded images.

#### 8. SUMMARY of INTENDED USE

This device is a digital radiography used in diagnostic X-ray angiography system configuration.

This X-ray angiography system is indicated for use in diagnostic and interventional procedures for cardian blood vessels, cerebral blood vessels, abdominal blood vessels and lower limb blood vessels.

It is intended to replace images obtained through the image intensifier technology.

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### EQUIVAALENCY INFORMATION 9.

1

TOSHIBA Medical Systems Corporation believes that the new Digital Radiography System, model DFP-8000/FDP is substantially equivalion to the current Digital Hadiography System, model
DFP-8000D/FDP is substantially equivalent to the current Digital Radiography System, DFP-800D with Image Intensifier (model RTP16301J-G1E) (K013608) except for the new Flat
Page Delector (FPD) Panel Detector (FPD).

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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes a symbol with three curved lines and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The symbol is positioned to the left of the text.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K052884

Trade/Device Name: Digital Radiography System with Flat Panel Detector Model: DFP-8000D/FPD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: October 10, 2005 Received: October 13, 2005

Dear Mr. Job:

This letter corrects our substantially equivalent letter of October 26, 2005.

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.

JUL 30 2012

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 [phone]. 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 [phone] or [phone] 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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## Indications for Use

510(k) Number (if known):

Ko52884

Device Name: Digital Radiography System with Flat Panel Detector, Model DEP-8000D/FDP

Indications for Use:

This device is a digital radiography system used in diagnostic X-ray angiography system configuration.

This X-ray angiography system is indicated for use in diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower limb blood vessels.

It is intended to replace images obtained through the image intensifier technology.

Prescription Use
(Part 21 CFR 801 Subpart D)

OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Croglon
**Division Sign-Off**

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number_ K05-2884