STINGRAY DR, MODEL 1

K992794 · Infimed, Inc. · MQB · Nov 9, 1999 · Radiology

Device Facts

• Record ID: K992794
• Device Name: STINGRAY DR, MODEL 1
• Applicant: Infimed, Inc.
• Product Code: MQB · Radiology
• Decision Date: Nov 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Stingray DR Solid State X-ray Imaging Device is intended for use in general radiographic examinations and applications wherever conventional screen-film systems may be used (excluding fluoroscopy, angiography, and mammography).

Device Story

Stingray DR is a digital radiography system using a flat-panel detector (CsI scintillator with a-Si TFT array) to convert X-rays into digital images. Operated by clinicians in general radiology settings, it replaces traditional screen-film systems. The system includes a Pentium-based PC for image storage, retrieval, and post-processing. Operators use a graphical user interface to modify output look-up tables and perform image corrections, potentially salvaging images with suboptimal exposure techniques. Output is viewed by healthcare providers to assist in clinical diagnosis. Benefits include improved image management and the ability to enhance data visibility through digital post-processing.

Clinical Evidence

Bench testing only. Performance data demonstrated spatial resolution of 3.5 lp/mm, equivalent to Philips and Siemens predicates and superior to the Canon system. No clinical studies were required for this determination.

Technological Characteristics

Flat-panel detector: Trixell a-Si sensor array with CsI scintillator; 17"x17" active area; 143-micron pixel size; 14-bit dynamic range. Connectivity: DICOM 3.0. Processing: Pentium-based PC running Windows NT. Image resolution: 3.5 lp/mm. Power: 110/120V or 230/240V, 50/60Hz.

Indications for Use

Indicated for general radiographic examinations in patients requiring diagnostic imaging where conventional screen-film systems are used, excluding fluoroscopy, angiography, and mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Philips Digital Diagnost (K982795)
• Siemens THORAX FD (K983732)
• Siemens MULTIX FD (K983732)
• Canon Digital Radiography System (K981556)
• GE Revolution XQ/i (K982196)

Submission Summary (Full Text)

{0}------------------------------------------------

NUV - 9 1999

**510(k) Summary of Safety and Effectiveness**

K992794

Date Prepared: August 16, 1999 Name of Contact Person: Ralph J. Flatau Address: InfiMed, Inc 121 Metropolitan Drive Liverpool NY 13088 Phone: [phone] x224 Fax: [phone]

Device trade name: Stingray DR Common name: Digital Radiography System Classification Name: Solid State X-ray Imager (SSXI)

### Device Description:

The Stingray DR system uses a flat panel x-ray detector that contains a CsI Scintillator and a Amorphous Si TFT array for conversion of X-rays into an electronic digital image. This system is to be used as a replacement for Screen film x-ray devices for X-ray images. The Stingray DR system has a Personal computer that is used for image storage and retrieval and image processing. The system allows for post processing of images. This allows for the potential to use images that might have been useless if taken on film due to, for example, incorrect technique since the Stingray DR system can post process the images, modify the output look up table and possibly bring out data that could not be seen under normal circumstances.

#### Intended Use:

The Stingray DR Solid State X-ray Imaging Device is intended for use in general radiographic examinations and applications wherever conventional screen-film systems may be used (excluding fluoroscopy, angiography, and mammography).

### Conclusions drawn from comparison:

The Stingray DR system performs the same functions in the same environment as the other 510(k) approved devices. The Stingray DR system uses the same sensor as the Philips Digital Diagnost and the Siemens THORAX FD and MULTIX FD. the Trixell Pixium 4600 Digital Detector for Radiography. And as shown in the performance data section the InfiMed Stingray DR system has demonstrated the same resolution, up to 3.5 lp/mm as that claimed by the Philips and Siemens systems and better spatial resolution than the Canon system. This would imply that the only part of the Stingray DR system that would be different from the Philips system and the Siemens system, the defect compensation and image correction algorithms, results in the same image resolutions as the predicate devices.

{1}------------------------------------------------

## Substantially equivalent devices and comparison:

| Feature/Item | InfiMed Stingray<br>DR | Phillips Digital<br>Diagnost | Siemens:<br>THORAX FD and<br>MULTIX FD | Canon Digital<br>Radiography<br>System | GE Revolution<br>XQ/i |
|--------------------------------|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------|
| 510(k) number | N/A | K982795 | K983732 | K981556 | K982196 |
| Flat Panel<br>Producer | Trixell | Trixell | Trixell | Canon | GE |
| Detector Material | a-Si sensor array<br>with CsI<br>scintillator | a-Si sensor array<br>with CsI<br>scintillator | a-Si sensor array<br>with CsI<br>scintillator | Scintillator over a<br>a-Si with a thin-<br>film-transistor<br>array | a-Si sensor array<br>with CsI<br>scintillator |
| Detector<br>Dimensions | 17" x 17" | 17" x 17" | 17" x 17" | 17" x 17" | Not Available |
| Pixel Size | 143 x 143<br>microns | 143 x 143<br>microns | 143 x 143<br>microns | 160 × 160<br>microns | Not Available |
| Detector Element<br>Matrix | 2981 x 3021 | 2981 x 3021 | 2981 x 3021 | 2688 X 2688 | Not Available |
| Dynamic Range | 14 bits | 14 bits | 14 bits | 14 bits | Not Available |
| Spatial Resolution | 3.5 lp/mm | Up to 3.5 lp/mm | 3.5 lp/mm | 3.1 lp/mm | Not Available |
| External<br>Connectivity | DICOM 3.0<br>compatible | DICOM 3.0<br>compatible | DICOM 3.0<br>compatible | DICOM 3.0<br>compatible | Not Available |
| Operator Console | Graphical User<br>Interface based | Graphical User<br>Interface based | Graphical User<br>Interface based | Graphical User<br>Interface based | Graphical User<br>Interface based |
| Image Processor | Pentium based PC | Sun Ultra SPARC | Pentium based PC | Pentium based PC | Not Available |
| Image Storage | Hard Drive | Hard Drive | Hard Drive | Hard Drive | Not Available |
| Operating System | Windows NT | UNIX | Windows NT | Windows NT | Not Available |
| Total Image<br>Processing time | 30 seconds per<br>image | Not Available | Not available | 30 seconds per<br>image | Not Available |
| ROI view | Yes | Unknown | Unknown | Yes | Unknown |
| Power<br>Requirements | 110/120V.<br>230/240V<br>50/60Hz | 230V 50/60Hz | Not Available | 110/120V,<br>230/240V<br>50/60Hz | Not Available |

# Table of Comparison To 510(k) Approved SSXID

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 1999

Ralph J. Flatau Quality Assurance Manager InfiMed., Inc. 121 Metropolitan Drive Liverpool, NY 13088

Re:

K992794 Stingray DR, Model 1 (SSXI System) Dated: August 19, 1999 Received: August 19, 1999 Regulatory class: II 21 CFR 892.1650/Procode: 90 MOB

Dear Mr. Flatau:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use Statement

510(k) Number

K992794

Unknown at this time

Device Name Stingray DR Solid State X-ray Imaging Device.

## Indications for Use

The Stingray Solid State X-ray Imaging Device is intended for use in general radiographic examinations and applications wherever conventional screen-film systems may be used (excluding fluoroscopy, angiography, and mammography).

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

Concurrence of CDRH, Office of Device Evaluation ( DOE)

Prescription Use

Per 21 CFR 801.109

Or

Over the counter Use

( Optional format 1-2-96)

Daniel A. Levenson
(Division Sign-Off)

( Division of Reproductive, Abdominal, ENT, and Radiological Dev. 510(k) Number