(35 days)
No
The document describes a standard digital X-ray system and does not mention any AI or ML capabilities in the device description, intended use, or performance studies.
No.
The device is described as a "Digital Diagnostic X-Ray System" used for "taking diagnostic radiographic exposures," indicating its purpose is for diagnosis rather than therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is for "taking diagnostic radiographic exposures."
No
The device description clearly outlines hardware components such as a ceiling mounted tubehead/collimator, digital panels, and tables, indicating it is a physical X-ray system with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The MAK 1500, MAK 2000, and MAK 3000 are Digital Diagnostic X-Ray Systems. They use X-rays to create images of the inside of the body. This is an in vivo diagnostic method (performed on a living organism), not an in vitro method (performed outside the body).
- Intended Use: The intended use clearly states it's for taking diagnostic radiographic exposures of various body parts. This involves imaging the patient directly, not analyzing samples from the patient.
Therefore, based on the provided information, this device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The MAK 1500, MAK 2000, MAK 3000 Digital Diagnostic X-Ray System (STATIONARY). (Digital Diagnostic X-Ray Systems) are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Product codes (comma separated list FDA assigned to the subject device)
90 KPR, MQB
Device Description
The MAK 1500 employs a ceiling mounted tubehead/collimator combination made by Suinsa, the NOVA . The system has one digital panel inside the universal bucky in the chest stand. It employs the Suinsa NBS-2100 Universal Bucky. The MAK 2000 uses a conventional vertical column mount and adds a Suinsa NET-4100 table. The MAK 3000, like the MAK 1500, employs a ceiling mount and universal bucky in the chest stand and adds the Suinsa NET-4100 table with a digital panel mounted inside. The digital pancl is the same one we supplied in K080582, manufactured by DRTcch Corporation (K080064) and the software is also unchanged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts.
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician
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 results of bench and standards testing indicates that the new device is as safe and effective as the predicate devices.
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.
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.
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.
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510(k) Summary
K082798
MedicaTech USA 50 Maxwell Irvine , CA , 92618 Toll Free : +1 800 817 5030 Phone : +1 949 679 2881 FAX : +1 949 679 2882 September 8, 2008 Contact: Ashraf Stefan , CEO
OCT 2 8 2008
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- Identification of the Device: Proprietary-Trade Name: MAK 1500, MAK 2000, MAK 3000 Digital Diagnostic X-Ray System (STATIONARY). Classification Name: Stationary X-ray system. Product Codes Product Code 90 KPR and MQB Common/Usual Name: General purpose diagnostic X-ray Unit.
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- Equivalent legally marketed devices: This notification is for a MODIFIED device. The device represents a variation of the tubehead mounting method described in our 510(k) number K080582.
-
- Indications for Use (intended use) These digital X-Ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull. spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
-
- Description of the Devices:
The MAK 1500 employs a ceiling mounted tubehead/collimator combination made by Suinsa, the NOVA . The system has one digital panel inside the universal bucky in the chest stand. It employs the Suinsa NBS-2100 Universal Bucky. The MAK 2000 uses a conventional vertical column mount and adds a Suinsa NET-4100 table. The MAK 3000, like the MAK 1500, employs a ceiling mount and universal bucky in the chest stand and adds the Suinsa NET-4100 table with a digital panel mounted inside. The digital pancl is the same one we supplied in K080582, manufactured by DRTcch Corporation (K080064) and the software is also unchanged.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and standards testing indicates that the new device is as safe and effective as the predicate devices.
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol appears to be a stylized representation 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
Medicatech USA % Mr. Daniel Kamm Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015
AUG - 9 2013
Re: K082798
Trade/Device Name: Model MAK 1500, MAK2000, MAK 3000 Digital Diagnostic X-Ray System (Stationary). (Digital Diagnostic X-Ray System) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system
Regulatory Class: II Product Code: KPR and MOB Dated: September 19. 2008 Received: October 2, 2008
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of October 28, 2008.
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
2
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
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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| Indications for Use | ||
|---|---|---|
| 510(k) Number (if known): | K082798 |
Device Name: Model MAK 1500, MAK 2000, MAK 3000 Digital Diagnostic X-Ray System (STATIONARY). (Digital Diagnostic X-Ray Systems)
Indications For Use:
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The MAK 1500, MAK 2000, MAK 3000 Digital Diagnostic X-Ray System (STATIONARY). (Digital Diagnostic X-Ray Systems) are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Heidi Heitman
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Division Sign-Off Division of Reproductive. Abdominal. and Radiological Devi
510(k) Number K082778