(71 days)
Not Found
No
The summary describes a standard digital image acquisition system for X-ray imaging, focusing on image capture, digitalization, review, and DICOM formatting. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic image processing.
No
The device is described as a "digital image acquisition system" for capturing and processing images during X-ray examinations, which is a diagnostic function, not a therapeutic one.
No
Explanation:
The device is described as a "DIGITAL IMAGE ACQUISITION SYSTEM" that "CAPTURES IMAGES," "DIGITALIZES THE IMAGE," "REVIEW IMAGES AND FORMAT IMAGES." Its purpose is to acquire and process images for viewing and transmission, not to provide a medical diagnosis itself. While the output images may be used by a clinician for diagnosis, the device's function is image acquisition and management, not diagnostic interpretation.
No
The device description explicitly states it includes a "camera" to capture images, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a "DIGITAL IMAGE ACQUISITION SYSTEM TO BE USED IN CONJUCTION WITH AN IMAGE INTESIFIER DURING RADIOGRAPHY OR FLUOROSCOPY X-RAY EXAMINATION TO CAPTURE IMAGES". This involves capturing images of the body using X-rays, not analyzing samples from the body.
- Intended Use: The intended use is for capturing and processing radiographic and fluoroscopic images, which are in vivo (within the living body) diagnostic procedures, not in vitro.
Therefore, this device falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The NICAL NDR+ is a digital image acquisition system to be used in conjunction with an image Intensifier during radiography or fluoroscopy x-ray examination to capture images by a camera, digitalize the image, review images and format images according to DICOM 3.0 protocol to be sent through network connection.
Product codes
892.2050, 892.1650, MQB
Device Description
The NICAL NDR+ is a digital image acquisition system to be used in conjunction with an image Intensifier during radiography or fluoroscopy x-ray examination to capture images by a camera, digitalize the image, review images and format images according to DICOM 3.0 protocol to be sent through network connection.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
Image /page/0/Picture/0 description: The image shows a 3D rendering of the word "NICE!" in block letters. The letters are white and stand out against a dark background. The perspective is slightly angled, giving a sense of depth to the image. The word is set on a rectangular base, which adds to the three-dimensional effect.
JAN 6 2006
Attachment 1 - 510 (k) SUMMARY
510(k) summary for NDR+- DIVA-D
Identification
| Applicant | NICAL SPA
43 Via Soffredini
Milan (MI), ITALY 20126
Registration Number: 3003314115 |
|-------------------------------|-------------------------------------------------------------------------------------------------|
| Contact Person | Mr. Roberto Niccolucci - President |
| Telephone (applicant) | +39 022571110 |
| Designated Agent
in the US | Mr. Gerald Silverman
71 Rose Street
Hasting On Hudson, NY 10706
Phone: +1 914 674 1085 |
| Manufacturing site | NICAL SPA
43 Via Soffredini
Milan (MI), ITALY 20126
Registration Number: 3003314115 |
Trade name: NDR+/DIVA-D
Common name: Digital image acquisition system Classification:
The equipment is classified as a class II
CFR21- 892.2050: Picture archiving and communication system
CFR21 - 892.1650: Image Intensified Fluoroscopic X-ray system.
Substantial equivalent device: the NDR+/DIVA-D is defined as Substantially Equivalent (SE) to the INFIMED Platinum ONE digital image acquisition system (certified under the name ORION) (K012490).
The following table compares the NDR+/DIVA-D and the predicate device
1
Image /page/1/Picture/0 description: The image shows a 3D rendering of the word "NIETL" in block letters. The letters are white and stand out against a dark background. The perspective suggests a slightly elevated viewpoint, giving a sense of depth to the image.
1
| FEATURES | NICAL (NDR+/DIVA D) | INFIMED (Platinum ONE) |
|---|---|---|
| Intended use | The NICAL NDR+ is a digital image | |
| acquisition system to be used in | ||
| conjunction with an image Intensifier | ||
| during radiography or fluoroscopy x- | ||
| ray examination to capture images by | ||
| a camera, digitalize the image, review | ||
| images and format images according | ||
| to DICOM 3.0 protocol to be sent | ||
| through network connection | The INFIMED Orion Fluoroscopic | |
| imaging system is a high resolution, | ||
| digital imaging system designed for | ||
| digital videography. It is intended to | ||
| replace conventional film techniques | ||
| in multipurpose or dedicated | ||
| applications where general | ||
| fluoroscopy, interventional | ||
| fluoroscopy or angiography or | ||
| cardiac imaging procedures are | ||
| performed. | ||
| The Orion system allows the | ||
| operator to view and enhance 1000 | ||
| line fluoroscopy. High resolution | ||
| digital spot images ( 1024x1024) | ||
| may be acquired at single or rapid | ||
| acquisition rates. Images may be | ||
| viewed and enhanced enabling the | ||
| operator to bring out diagnostic | ||
| details difficult or impossible to see | ||
| using conventional imaging | ||
| techniques. | ||
| The Orion system enables the | ||
| operator to hardcopy image with a | ||
| laser printer or send images over a | ||
| network. The major system | ||
| components include: a fluoroscopic | ||
| TV camera, monitors, and an image | ||
| processor. · | ||
| Image Acquisition | CCD camera 1024x1024 12 bit | CCD camera 1024x1024 12 bit |
| Speed Acquisition | 1024x1024 at 25 fps for FLUORO and | |
| all radiographic exams | Up to 30 fps for FLUORO | |
| acquisition and up to 15 fps for spot | ||
| acquisition | ||
| Edge Enhancer | Completely hardware in real time | Software package |
| Start Up System | Automatic hardware and software test | |
| for each ignition | Automatic system calibration and | |
| remote system diagnostics | ||
| Noise Reduction | Dynamic recursive filter which | |
| offering an automatic noise/blurring | ||
| optimization effect it gives zero | ||
| persistence | Standard recursive filter | |
| Image Storage | Up to 36000 frames with matrix | |
| 1024x1024. | ||
| All the images are stored directly from | ||
| the CCD camera head without any | ||
| kind of edge enhancement and digital | ||
| compression. | NA | |
| Post Processing | ||
| Working | All the images stored in the system can | |
| be elaborated in order to modify the | ||
| windowing, the gray scale, the zoom, | ||
| the annotation package, the edge | ||
| enhancement and the noise reduction | Brightness/contrast polarity | |
| enhancement. Measurement and | ||
| annotation package | ||
| DSA Application | Real time mask subtraction, road | |
| mapping, land marking, pixel shift | ||
| function, auto loop replay, injector | ||
| synchronization, automatic or manual | ||
| possibility to change the mask, maxop | ||
| function and stepping angio | Real time mask subtraction, road | |
| mapping, land marking, percent | ||
| Stenosis vascular package, auto loop | ||
| replay, injector synchronization. | ||
| Multi Image | Thumbnail image viewing with the | |
| possibility to choose the first image for | ||
| every run or the 50% of the run. | Thumbnail image viewing | |
| DICOM Functions | Full DICOM 3.0 integrated | Full DICOM 3.0 integrated |
| Laser Interface | When DICOM network is not | |
| available in the site installation, it is | ||
| possible to send the images to a laser | ||
| printer using the protocol P831 or | ||
| P859 | NA | |
| Interface Commands | Flat keyboard with waterproof surface | Standard pc keyboard + standard pc |
| mouse |
510(K) Summary for NDR+/DIVA-D
2
Image /page/2/Picture/0 description: The image shows a logo with the letters "NICA" in a stylized, three-dimensional font. The letters are slanted and appear to be embossed or raised from a dark, solid background that is shaped like a geographical region. The logo has a simple, bold design and is likely associated with an organization or entity named NICA.
Indication for use.
The indication for use of the NDR+/DIVA-D is: DIGITAL IMAGE ACQUISITION SYSTEM TO BE USED IN CONJUCTION WITH AN IMAGE INTESIFIER DURING RADIOGRAPHY OR FLUOROSCOPY X-RAY EXAMINATION TO CAPTURE IMAGES BY A CAMERA, DIGITALIZE THE IMAGE, REVIEW IMAGES AND FORMAT IMAGES ACCORDING TO DICOM PROTOCOL TO BE SENT THROUGH NETWORK CONNECTION
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in blue text. To the left of the text is a circular emblem with a stylized image of a human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
NICAL SPA % Mr. Gerald Silverman Designated Agent 71 Rose Street Hasting on Hudson, NY 10706
AUG 2 3 2013
Re: K053029
Trade/Device Name: NDR+/DIVA-D Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 27, 2005 Received: November 25, 2005
Dear Mr. Silverman:
This letter corrects our substantially equivalent letter of January 6, 2006.
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
4
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. Morri Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows a black and white picture of a structure with the word "NIECO" on it. The structure appears to be made of concrete or stone. The word "NIECO" is written in large, bold letters across the front of the structure. The image is a low-resolution image.
6.1. Indication for use Statement
510(k) Number: Kos 30 2 7
Device Name: NDR+ or DIVA-D
The indication for use of the NDR+/DIVA-D is: DIGITAL IMAGE ACQUISITION SYSTEM TO BE USED IN CONJUCTION WITH AN IMAGE RADIOGRAPHY INTESIFIER DURING OR FLUOROSCOPY X-RAY EXAMINATION TO CAPTURE IMAGES BY A CAMERA, DIGITALIZE THE IMAGE, REVIEW IMAGES AND FORMAT IMAGES ACCORDING TO DICOM PROTOCOL TO BE SENT THROUGH NETWORK CONNECTION
Daniel A. Lysom
Division Sign-Off ivision of Reproductive. Abdominal nd Radiological Devic
Prescription Use