(33 days)
No
The document does not mention AI, ML, or related concepts, and the description focuses on traditional imaging system components and techniques.
No
The device is described as a "diagnostic imaging device" intended for "radiographic, fluoroscopic, angiographic, and interventional applications" which are diagnostic procedures, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Philips OmniDiagnost is a diagnostic imaging device..."
No
The device description explicitly lists multiple hardware components including an X-Ray system, generator, tube, collimator, II-TV subsystem, monitors, and control desks.
Based on the provided information, the Philips OmniDiagnost is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- OmniDiagnost Function: The description clearly states the OmniDiagnost is a diagnostic imaging device that uses X-rays to visualize the inside of the body. It performs radiographic, fluoroscopic, angiographic, and interventional procedures. These are all in-vivo (within the living body) diagnostic methods.
- No Mention of Samples: There is no mention of the device analyzing samples taken from the body.
Therefore, the Philips OmniDiagnost falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Philips OmniDiagnost is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.
Product codes
90JAA
Device Description
The OmniDiagnost is a multifunctional, universal, overtable X-Ray system offering fluoroscopic, radiographic, angiographic and interventional techniques in a wide variety of applications. The OmniDiagnost employs a scanning concept, whereby the column with X-Ray tube and Image Intensifier moves while the table remains fixed. The basic system is composed of the OmniDiagnost stand, X-Ray generator, X-Ray tube and collimator, II-TV subsystem and monitors, Control Desks, Digital Acquisition System (DSI (K920793)), and Easy Vision (initially introduced under K920950).
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
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)
Philips Diagnost 96, K912470
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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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SEP 2 9 1999
Image /page/0/Picture/1 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in a sans-serif font above a circular emblem. The emblem contains two wavy lines representing water, with a four-pointed star above and below the wavy lines. The logo is black and white.
Philips Medical Systems
510(k) Summary
| Company name: | Philips Medical Systems North America Company |
|---|---|
| Address: | 710 Bridgeport Avenue, Shelton, CT 06484 |
| Contact person: | Peter Altman |
| Telephone number: | 203-926-7031 |
| Prepared: | August 25, 1998 |
| Device name: | Philips OmniDiagnost |
| Classification name: | Fluoroscopic X-Ray System, 90JAA, 21 CFR 892.1680 |
| Common/Usual name: | Remote-controlled Radiographic/Fluoroscopic System |
| Predicate Device(s): | Philips Diagnost 96 |
Intended use:
The Philips OmniDiagnost is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.
System description:
The OmniDiagnost is a multifunctional, universal, overtable X-Ray system offering fluoroscopic, radiographic, angiographic and interventional techniques in a wide variety of applications. The OmniDiagnost employs a scanning concept, whereby the column with X-Ray tube and Image Intensifier moves while the table remains fixed.
The basic system is composed of the OmniDiagnost stand, X-Ray generator, X-Ray tube and collimator, II-TV subsystem and monitors, Control Desks, Digital Acquisition System (DSI (K920793)), and Easy Vision (initially introduced under K920950).
Substantial equivalence Information
The OmniDiagnost is a modification of, and substantially equivalent to the Philips Diagnost 96 system (FDA ref. K912470).
Safety Information
The Philips OmniDiagnost complies with the applicable portions of 21 CFR parts 1020.30/.31/.32 and voluntary safety standards, such as UL 2601. The Information for Users contains comprehensive information to insure safe and effective use.
Philips Medical Systems
North America Company
710 Bridgeport Avenue
P.O. Box 860
Shelton, Connecticut 06484-0917
Tel: (203) 926-7674
Fax: (203) 929-6099
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Peter Altman Director of Regulatory Affairs Phillips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917 Re:
K982993 Philips OmniDiagnost Dated: August 26, 1998 Received: August 27, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 JAA
Dear Mr. Altman:
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We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Pederal Food, Drug, and Cosmetic Act (Act). 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 probibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdch/dsmald.html".
Sincerely yours,
Kilian Yi
Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/1/Picture/14 description: The image is a blank white square. There are no objects or figures in the image. The image does not contain any text. The image is completely white.
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510(k) Number (if known): ______________ Unknown
Philips OmniDiagnost Device Name : ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Indications For Use :
The Philips OmniDiagnost is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Gamil A. Siyoum
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devic
510(k) Number K982493
Prescription Use
(Per 21 CFR 801.109
14
............
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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