(310 days)
Not Found
No
The summary describes a standard digital X-ray system and does not mention any AI or ML components or functionalities.
No.
The device is clearly indicated for diagnostic radiographic exposures and does not mention any therapeutic use.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the system is "intended for use...for taking diagnostic radiographic exposures," and the 'Device Description' also refers to it as a "digital diagnostic x-ray system."
No
The device description explicitly lists hardware components such as a Solid State Xray Imager (Flat Panel), tube-collimator assembly, generator, and operation control unit.
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 detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Description: The provided description clearly states that the DRC-1000 is a "Digital X-ray Imaging System" used for taking "diagnostic radiographic exposures" of various body parts. This involves using X-rays to create images of the internal structures of the body within the living patient.
The device's function is entirely based on imaging the body directly, not on analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
Digital X-ray Imaging System, DRC-1000, is 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, extremities, and other body parts. Not to be used for fluoroscopy, angiography, or screening mammography. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Product codes
KPR
Device Description
DRC-1000 is a digital diagnostic x-ray system which consists of Solid State X-ray Imager (Flat Panel), tube-collimator assembly mounted on a U-Arm, generator and operation control unit. DRC-1000 is designed for adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, spinal column, chest, 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)
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. All test results were satisfactory.
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
510(k) Submission -- DRC-1000
510(k) Summary
Date: July 27, 2009
-
- Submitter:
Company Name Company Address
- Submitter:
U.S. Agent Address:
Contact Person Telephone Fax
- Device :
Reason for 510(k) Manufacturer Model Name: Common Name Classification Name :New Model : Vatech Co., Ltd. : DRC-1000 : Digital X-ray imaging system : SYSTEM, X-RAY, STATIONARY
-
- Predicate Device :
| Manufacturer | : Sedecal, Inc. |
|---|---|
| Model Name | : Sedecal X-Plus LP Plus Digital |
| Classification Name | : SYSTEM, X-RAY, STATIONARY |
| 510(k). Number | : K090238 (Decision Date - Feb. 27. 2009) |
: Vatech Co., Ltd.
Secaucus, NJ 07094
: (832)-623-2099
: (713)-464-8880
: Dave Kim
: 23-4, Seogu-Dong, Hwaseong-si,
Gyeonggi-do, 445-170, Korea
333 Meadowlands Parkway, #303
4 . Classifications Names & Citations :
21CFR 892.1680, KPR, System, X-ray, Stationary, Class2
Vatech Co., Ltd.
JUL 2-1 2010
1
- Description :
5.1 General
DRC-1000 is a digital diagnostic x-ray system which consists of Solid State Xray Imager (Flat Panel), tube-collimator assembly mounted on a U-Arm, generator and operation control unit. DRC-1000 is designed for adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
5.2 Product features
a. Condition of Input
1-1. Rated input voltage : AC 220V / AC 110V
1-2. Guaranteed working voltage
l) 110V Mode : 100 ~120V
- 220V Mode : 200~240V
1-3. Possible working voltage
-
110V Mode : 90~130V
-
220V Mode : 180 ~ 250V
1-4. Rated input frequency : 50Hz/60Hz
1-5. Insulation withstanding : below than 1.5KV cap for more than one minute between first test and second test.
b. Capture Mode
Whole body
Shooting Mode : CHEST/RIB/STERNUM/APEX/SELLA ..
- Indication for use :
Digital X-ray Imaging System, DRC-1000, is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic
2
510(k) Submission --DRC-1000
exposures of the skull, spinal column, chest, extremities, and other body parts.
Not to be used for fluoroscopy, angiography, or screening mammography. Applications can
be performed with the patient sitting, standing, or lying in the prone or supine position.
- Comparison with predicate device :
Vatech Co., Ltd., believes that the DRC-1000 is substantially equivalent to the Sedecal X-Plus LP Plus Digital of Sedecal, Inc.
- Safety, EMC and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. All test results were satisfactory.
9. Conclusion :
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Vatech Co., Ltd. concludes that The DRC-1000 is safe and effective and substantially equivalent to predicate devices as described herein.
- Vatech Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
END
Vatech Co., Ltd.
page 3 of 3
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged in a semi-circular fashion around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Vatech Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Consultant Vatech America 333 Meadowlands Parkway, #303 SECAUCUS NJ 07094
JUL 2 1 2010
Re: K092830
Trade/Device Name: Digital X-ray Imaging System / DRC-1000 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: January 14, 2010 Received: January 19, 2010
Dear Mr. Kim:
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 (reporting of
4
Page 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/ReportalProblem/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.
Amold J. Roth
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number(if known): K092830
Device Name: Digital X-ray Imaging System / DRC-1000
Indications for Üse:
Digital X-ray Imaging System, DRC-1000, is intended for by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, extremities, and other body parts. Not to be used for fluoroscopy, angiography, or screening mammography. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Braination Care
ASB
(Division Sign-Off) (Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety .
510K K092803
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