(15 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML-powered devices.
No
The device is an x-ray system intended for obtaining diagnostic images, not for therapeutic purposes.
No
Explanation: The device is an x-ray system intended for obtaining radiographic images, which is an imaging device. While imaging can be used for diagnosis, the device itself produces images, not a diagnosis.
No
The device description explicitly states it is a "stationary x-ray system" with physical components like a tube stand, table, and wall stand, indicating it is a hardware device.
Based on the provided information, the 0170 Intuition is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "obtaining radiographic images of various portions of the human body in a clinical environment." This describes an imaging device used on the human body, not a device used to test samples from the human body (which is the core function of an IVD).
- Device Description: The description details a stationary x-ray system with components like a tube stand, table, and wall stand. This aligns with the description of an imaging system, not a laboratory or testing device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, assays, or any other elements typically associated with in vitro diagnostics.
In summary, the 0170 Intuition is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 0170 Intuition is a stationery x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The 0170 Intuition is not intended for mammography.
Product codes
KPR
Device Description
The 0170 Intuition is a stationary x-ray system with a ceiling mounted tube stand, a floor mounted table and a wall stand that has a floor mounted column with a detector holder. The ceiling stand and the table has automatic movements for up and downs, other movements are manual. The standard equipment includes a graphic display showing X-ray tube rotation and film focus or source image distance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
various portions of the human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical environment.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Q-Rad Radiographic System manufactured by Quantum Medical Imaging LLC, K011486, Xplorer 2200 Digital Radiographic System manufactured by Imaging Dynamics Company Ltd, K063039, DAR7000 RADspeed SAFIRE manufactured by Shimadzu Corporation. K050925
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 the word "ARCOMA" in a simple, sans-serif font. To the left of the word is a stylized logo consisting of three curved lines converging to form a triangular shape. The logo and the text are both in black and stand out against a white background.
JAN 10 2008
510 (k) Summery
Date of summery: November 26, 2007
Submitter/Manufacturer/Applicant:
Arcoma AB Annavagen 1 SE-352 46 Vaxio Sweden Contact person: Bengt-Hugo Johansson Phone: +46 470 706925 Fax: +46 470 706999
Device Name and Classification
Trade name Classification name Review Panel Product Code Requlation Number Device classification Arcoma, Intuition Stationary x-ray system Radiology KPR 892.1680 Class II
Predicate device
-
- Q-Rad Radiographic System manufactured by Quantum Medical Imaging LLC, K011486
-
- Xplorer 2200 Digital Radiographic System manufactured by Imaging Dynamics Company Ltd, K063039
-
- DAR7000 RADspeed SAFIRE manufactured by Shimadzu Corporation. K050925
Device description
The 0170 Intuition is a stationary x-ray system with a ceiling mounted tube stand, a floor mounted table and a wall stand that has a floor mounted column with a detector holder.
The ceiling stand and the table has automatic movements for up and downs, other movements are manual.
The standard equipment includes a graphic display showing X-ray tube rotation and film focus or source image distance.
Intended use
The 0170 Intuition is a stationery x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment.
The 0170 Intuition is not intended for mammography
ARCOMA AB Annavagen 1 SE-352 46 Växjo weden
Telefon/Phone :46 (0)470 70 69 00 office@arcoma.se
Favitav -46 (0)470 70 69 99 5 - 1
1
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that represents the department's mission.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 10 2008
ARCOMA AB % Mr. Jay Y. Kogoma Official Correspondent Intertek Testing Services NA, Inc. 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K073632
Trade/Device Name: Intuition, Model 0170 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: December 21, 2007 Received: December 26, 2007
Dear Mr. Kogoma:
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 either class II (Special Controls) or class III (PMA), 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, FDA may publish further announcements concerning your device in the Federal Register.
2
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
COMA
Statement of Indication for Use
510(k) Number: K_073632
Device Name: Intuition, Model 0170
The 0170 Intuition is a stationery x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment.
The 0170 Intuition is not intended for mammography.
Prescription Use X (Part 21 CFR 801 Subpart D) And/OR
..
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tony K. Wh
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
4 - 1
ARCOMA AB Annavägen 1 SE-357 46 Växič SWATER
Telefon/Phone +46 (0)470 70 69 00 office@arcoma.se
46 (0)470 70 69 99