(82 days)
Not Found
No
The description mentions "image processing" and "post processing of images" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe functionalities typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, or diagnosis). The focus is on digital image manipulation and storage.
No
The device is described as an X-ray imaging system used for diagnosis, not for treating diseases or conditions.
No
Explanation: The device is an X-ray imaging system used to acquire images, not to interpret or diagnose medical conditions based on those images. Its function is analogous to a camera for medical purposes.
No
The device description explicitly mentions hardware components like a flat panel x-ray detector, CsI Scintillator, Amorphous Si TFT array, and a Personal computer, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "general radiographic examinations and applications wherever conventional screen-film systems may be used." This describes an imaging device used to capture images of the body, not to perform tests on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description focuses on the technology used to convert X-rays into digital images. This is consistent with an imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific substances, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is an imaging device used to visualize internal structures.
N/A
Intended Use / Indications for 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).
Product codes (comma separated list FDA assigned to the subject device)
90 MOB
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K982795, K983732, K981556, K982196
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.
0
NUV - 9 1999
510(k) Summary of Safety and Effectiveness
Date Prepared: August 16, 1999 Name of Contact Person: Ralph J. Flatau Address: InfiMed, Inc 121 Metropolitan Drive Liverpool NY 13088 Phone: (315)453-4545 x224 Fax: (315)453-4550
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
DR | Phillips Digital
Diagnost | Siemens:
THORAX FD and
MULTIX FD | Canon Digital
Radiography
System | GE Revolution
XQ/i |
|--------------------------------|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------|
| 510(k) number | N/A | K982795 | K983732 | K981556 | K982196 |
| Flat Panel
Producer | Trixell | Trixell | Trixell | Canon | GE |
| Detector Material | a-Si sensor array
with CsI
scintillator | a-Si sensor array
with CsI
scintillator | a-Si sensor array
with CsI
scintillator | Scintillator over a
a-Si with a thin-
film-transistor
array | a-Si sensor array
with CsI
scintillator |
| Detector
Dimensions | 17" x 17" | 17" x 17" | 17" x 17" | 17" x 17" | Not Available |
| Pixel Size | 143 x 143
microns | 143 x 143
microns | 143 x 143
microns | 160 × 160
microns | Not Available |
| Detector Element
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
Connectivity | DICOM 3.0
compatible | DICOM 3.0
compatible | DICOM 3.0
compatible | DICOM 3.0
compatible | Not Available |
| Operator Console | Graphical User
Interface based | Graphical User
Interface based | Graphical User
Interface based | Graphical User
Interface based | Graphical User
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
Processing time | 30 seconds per
image | Not Available | Not available | 30 seconds per
image | Not Available |
| ROI view | Yes | Unknown | Unknown | Yes | Unknown |
| Power
Requirements | 110/120V.
230/240V
50/60Hz | 230V 50/60Hz | Not Available | 110/120V,
230/240V
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 (301) 594-4613. 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"(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 (800) 638-2041 or (301) 443-6597, 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
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