(15 days)
Not Found
No
The summary describes a standard X-ray imaging system and does not mention any AI or ML components or functionalities.
No
The document states its intended use is for "diagnostic-imaging" and describes it as an "X-ray system," rather than for treating medical conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Philips OmniDiagnost Eleva is a diagnostic-imaging device..."
No
The device description clearly outlines a physical X-ray system with hardware components like a floor-mounted stand, tilting patient support table, X-ray generators, image intensifier, X-ray tubes, and TV monitors. This is not a software-only device.
Based on the provided information, the Philips OmniDiagnost Eleva is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a "diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications." These are all imaging techniques that use external energy (X-rays) to visualize internal structures of the body.
- Device Description: The description details an X-ray system with components like an X-ray tube, image intensifier, and patient support table. These are characteristic of imaging systems, not devices that analyze biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are designed to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or screening purposes. The Philips OmniDiagnost Eleva operates by generating images of the body itself, not by analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The Philips OmniDiagnost Eleva is a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.
Product codes (comma separated list FDA assigned to the subject device)
90 IZI, JAA, and KPR
Device Description
The Philips OmniDiagnost Eleva is a multifunctional, universal, overtable X-ray system offering radiographic, fluoroscopic, angiographic, and interventional techniques in a wide variety of applications. The Philips OmniDiagnost Eleva consisting of a floor mounted stand with an integrated tilting patient support table is supported at only one end, allowing patient access from both sides.
As a fully integrated system, the Philips OmniDiagnost Eleva stand can be configured with X-ray generators from the Philips generator family and Philips digital spot film device. The system comes with a 38 cm multimode Image Intensifier, XTV imaging system, collimator for patient positioning without X-rays, Philips glass or metal X-ray tubes, and TV monitors.
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): 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.
Not Found
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
§ 892.1650 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.
0
JUL 17 2003
Image /page/0/Picture/1 description: The image shows the Philips logo, which consists of the word "PHILIPS" in bold, sans-serif font above a shield-shaped emblem. The emblem contains a stylized representation of radio waves or sound waves, with a circular shape and two horizontal wavy lines inside. There are also four stars or asterisks placed at the corners of the circular shape, adding a decorative element to the logo.
Philips Medical Systems Nederland B.V.
The following information is be bmitted in accordance with the requirements of 21 CFR 807.92.
| Company Name:
Address: | Philips Medical Systems North America Company
22100 Bothell Everett Highway
P.O.Box 3003
Bothell, WA 98041-3003, USA |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Registration No .: | 1217116 |
| Contact Person:
Telephone No .: | Lynn Harmer
(425) 487-7312 |
| Date Prepared: | June 12, 2003 |
| Device (Trade) Name: | Philips OmniDiagnost Eleva |
| Classification Names: | Stationary X-ray system,
21CFR892.1680, Class II (code 90KPR) |
| | Image-intensified fluoroscopic X-ray system,
21CFR892.1650, Class II (code 90JAA) |
| | Angiographic X-ray system,
21CFR892.1600, Class II (code 90IZI) |
Predicate Device:
The OmniDiagnost Eleva is substantially equivalent to the Philips OmniDiagnost manufactured by Philips Medical Systems. The OmniDiagnost system received a 510(k) substantially equivalent determination in K982993 on August 26, 1998.
Device description:
The Philips OmniDiagnost Eleva is a multifunctional, universal, overtable X-ray system offering radiographic, fluoroscopic, angiographic, and interventional techniques in a wide variety of applications. The Philips OmniDiagnost Eleva consisting of a floor mounted stand with an integrated tilting patient support table is supported at only one end, allowing patient access from both sides.
As a fully integrated system, the Philips OmniDiagnost Eleva stand can be configured with X-ray generators from the Philips generator family and Philips digital spot film device. The system comes with a 38 cm multimode Image Intensifier, XTV imaging system, collimator for patient positioning without X-rays, Philips glass or metal X-ray tubes, and TV monitors.
1
510(k) Summary Philips OmniDiagnost Eleva Page 2 of 2
Image /page/1/Picture/1 description: The image shows the Philips logo, which consists of the word "PHILIPS" in bold, sans-serif font above a shield-like emblem. The emblem features a stylized representation of radio waves or sound waves emanating from a central point, with additional star-like symbols placed above and below the waves. The logo is presented in black and white.
Image /page/1/Picture/2 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word is the primary focus of the image, taking up most of the space.
Intended use:
K∅3 2∅4L
The Philips OmniDiagnost Eleva is a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.
General Safety and Effectiveness:
The device and their labeling will comply with the applicable requirements of:
- 21 CFR, Subchapter J Radiological Health, parts 1020.30, 31, 32 .
- Underwriters Laboratories Standard for Safety UL 2601-1 and be classified by . Underwriters Laboratories.
- ACR/NEMA DICOM digital imaging communication standard. ●
Conclusion:
The Philips OmniDiagnost Eleva does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers the OmniDiagnost Eleva to be substantially equivalent with the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is a stylized depiction of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
JUL 17 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems North America Company % Mr. Marc Mouser Project Engineer/Program Manager Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607
Re: K032046
Trade/Device Name: Philips OmniDiagnost Eleva Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 IZI, JAA, and KPR Dated: June 30, 2003 Received: July 2, 2003
Dear Mr. Mouser:
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 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.
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.
3
Page 2
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
Enclosure
4
510(k) Number if Known):______________________________________________________________________________________________________________________________________________________
Device Name: Philips OmniDiagnost Eleva
Indications for Use:
The Philips OmniDiagnost Eleva is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
David R. Seymon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K032046