(51 days)
Not Found
Not Found
No
The provided text describes a standard digital X-ray system and does not mention any AI or ML capabilities, image processing beyond basic readout, or performance studies related to algorithmic analysis.
No.
The device is described as a "diagnostic system" used for "applying general radiography and orthopaedic examinations," which are diagnostic procedures, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "direct digital X-ray Radiography diagnostic system."
No
The device description clearly states it is a "direct digital X-ray Radiography diagnostic system" and includes a "one CCD X-ray detector (HD-3000)", indicating it is a hardware system with software components, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the living body (in vitro).
- Device Function: The description clearly states that the Swissray ddRCompact is an X-ray radiography system. It is used to take images of a patient's body directly (in vivo) for diagnostic purposes.
- No Sample Analysis: The description does not mention any analysis of biological samples. The device's function is to capture and display X-ray images.
Therefore, based on the provided information, the Swissray ddRCompact is a medical imaging device used for in vivo diagnostic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRCompact is a further development of the AddOn Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRCompact is configured with a one CCD X-ray detector (HD-3000) and is designed for applying general radiography and orthopaedic examinations on a patient in a supine, seated or standing position. The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.
Product codes
KPR
Device Description
The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRCompact is a further development of the AddOn Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRCompact is configured with a one CCD X-ray detector (HD-3000) and is designed for applying general radiography and orthopaedic examinations on a patient in a supine, seated or standing position.
Mentions image processing
Not Found
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
hospital or doctor practice X-ray room
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)
Not Found
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 circular logo with text around the perimeter and a stylized symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The central symbol consists of three curved lines that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Swissray Medical AG c/o Mr. John Monahan QA Manager Swissray International, Inc. 1180 McLester Street, Unit #2 ELIZABETH NJ 07201-2948
2 2007
Re: K070678
Trade/Device Name: ddRCompact Regulation Number: 21 CFR 8892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code; KPR Dated: March 8, 2007 Received: March 16, 2007
Dear Mr. Monahan:
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 Hoss metic Act (Act) that do not require approval of a premarket approval application (PMA), Your costi. 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 a 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 898. In addition, FFA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the text "PDA" in large, bold letters. Underneath "PDA" is the word "Centennial" in a smaller font. At the very bottom of the logo are three stars arranged horizontally. The logo appears to be for the centennial celebration of the PDA, spanning from 1906 to 2006.
Protecting and Promoting Public Health
1
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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Nancy C. Brygdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the word "Swissray" in a simple, sans-serif font. To the right of the word is a small, abstract graphic. The graphic is composed of several small squares arranged in a cluster.
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Section D
510 (K) Number (if known)
Device name : ddRCompact
Indication for Use
The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRCompact is a further development of the AddOn Multi System.
This system can be used in a hospital or doctor practice X-ray room.
The ddRCompact is configured with a one CCD X-ray detector (HD-3000) and is designed for applying general radiography and orthopaedic examinations on a patient in a supine, seated or standing position.
The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.
Prescription Use
Nancy C. Bordon
Division Sign-Off
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070678
(Please do not write below this line- continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (DOE)
Prescription Use or Over The Counter Use
(Optional Format 1-2-96) (Per 21 CFR 801.109)