(116 days)
N/A, K091345
No
The summary describes a standard digital X-ray imager that converts conventional X-ray images to digital format. There is no mention of AI, ML, or any advanced image processing beyond basic capture and display. The lack of information on training/test sets and performance metrics typically associated with AI/ML devices further supports this conclusion.
No
The device is described as an X-Ray Imager used for diagnostic imaging, not for treating diseases or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for physicians or technologists operating under the guidance of the physician, to use for diagnostic x-ray imaging in podiatric practices." The "Device Description" also mentions that the diagnostic image can be transmitted.
No
The device description explicitly states it is a "digital x-ray Imager" and is used to "directly capture and convert conventional projection X-Ray images to digital images." This indicates the device includes hardware components for image capture and conversion, not just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The SimonDR DRP Digital X-Ray Imager is used to capture and convert X-ray images of the human body (specifically the podiatric area) directly. It is an imaging device that works on the patient, not on a sample taken from the patient.
The description clearly states its purpose is for "diagnostic x-ray imaging in podiatric practices instead of using a film based system." This is a form of medical imaging, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The SimonDR DRP is a digital x-ray Imager intended for physicians, or technologists operating under the supervision of a physician, to use for podiatric x-ray instead of using a film based system.
Product codes
MQB
Device Description
The SimonDR Inc. model DRP is used to directly capture and convert conventional projection X-Ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for podiatric radiographic examinations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Podiatric
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians, or technologists operating under the supervision of a physician, to use for podiatric x-ray
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
N/A, K091345
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Section 5 - Revised 3/10/2010:
・
APR - 5 2010
:
. •
510(K) Summary (K093790)
| Prepared: | February 24, 2010 |
|---|---|
| Submitter: | |
| Company Name: | SimonDR Inc. |
| Company Address: | 3515 Marmenco Court |
| Baltimore, Maryland 21230 | |
| Contact Person: | Jason Simon, President |
| Official Correspondent: | Valerie Lohr, General Manager |
| Phone Number: | 410-636-5555 |
| Fax Number: | 410-636-4415 |
| Proposed Device: | |
| Reason For 510(K): | New Device |
| Manufacturer: | SimonDR Inc. |
| Trade Name: | SimonDR |
| Model Number: | DRP |
| Classification Name: | 90 MQB SSXI- Solid State X-Ray Imager |
| FDA 510(k)#: | Submission in progress |
| Predicate Device(s) 1: | |
| Manufacturer: | Kodak (Carestream) Lanex Screen/AGFA 1/2 Speed Film |
| Trade Name: | Kodak/Carestream |
| Model Number: | Lanex |
| Classification Name: | Radiographic film/screen system |
| FDA 510(k)#: | N/A |
| Manufacturer: | Canon Inc. |
| Trade Name: | Canon |
| Model Number: | CXDI-55G |
| Classification Name: | MQB, Solid State X-Ray Imager |
| FDA 510(k)#: | K091345 |
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Predicate Device(s) 2:
. "
Description of Device :
The SimonDR Inc. model DRP is used to directly capture and convert conventional projection X-Ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for podiatric radiographic examinations.
The full Device Comparison Table is found in section 12 of this application; however, in terms of . Resolution (MTF) and Dynamic Range the comparison with the digital and analog predicate device is found below.
| Characteristic | SimonDR Inc
Model DRP | Lanex Detail
Screen/Film
System
Device 1 |
|----------------|---------------------------------------------------------------|-----------------------------------------------------------------------|
| MTF | 4.0 lp/mm 35% | 4 -5 lp/mm 35% (see
also Section 18) |
| Dynamic Range | Up to 16 bit capture,
display ranging from
8 to 12 bits | Approximately
20(about 5 bits),
depending on film
processing |
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| Characteristic | SimonDR Inc.
Model DRP | Canon
Device 2 |
|----------------|---------------------------------------------------------------|-----------------------------------------------|
| MTF | 4.0 lp/mm 35% | MTF@2 lp/mm 40% |
| Dynamic Range | Up to 16 bit capture,
display ranging from
8 to 12 bits | (linear A/D: 14 bit)
(output data: 12 bit) |
Intended Use:
The SimonDR DRP is a digital x-ray Imager intended for physicians, or technologists operating under the supervision of a physician, to use for podiatric x-ray instead of using a film based system.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal
and Radiological Devices
510(k) Number _______________________
Prescription Use_XX__
OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
510(k) Summary Statement
I certify that in my capacity as President of Simon DR, Inc, I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent, The information I agree to make available will be a duplicate of the premarket notification including any adverse safety and effectiveness information, but excluding
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all patient identification, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.
・
Signed:
Torn Son
Jason Simon
President
Date: 2/24/2010
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of two parts: a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is written in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Valerie Lohr General Manager SimonDR, Inc. 3515 Marmenco Court BALTIMORE MD 21230
Re: K093790
Trade/Device Name: SimonDR DRP Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: March 11, 2010 Received: March 15. 2010
AUG 2 3 2013
Dear Ms. Lohr:
This letter corrects our substantially equivalent letter of April 5, 2010.
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.
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 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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
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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Section 4
Indications for Use Statement
510K number:
Submission in progress
Device Name:
SimonDR DRP
Indications For Use:
The Models SimonDR DRP Digital X-Ray Imager is a digital x-ray Imager intended for physicians or technologists operating under the guidance of the physician, to use for diagnostic x-ray imaging in podiatric practices instead of using a film based system.
11093790
(Division Sign-Off)
Office of In Vit
510K. K093700
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