← Product Code [IZI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI) · K023441

# PHILIPS MULTIDIAGNOST ELEVA (K023441)

_Philips Medical Systems · IZI · Oct 30, 2002 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K023441

## Device Facts

- **Applicant:** Philips Medical Systems
- **Product Code:** [IZI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI.md)
- **Decision Date:** Oct 30, 2002
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1600
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** 3rd-Party Reviewed

## Indications for Use

The Philips MultiDiagnost Eleva is intended for the same applications as the previous MultiDiagnost 4 and MultiDiagnost 3 systems. As a multi-functional/universal system. general R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialised interventional applications. This includes the following general areas. Digestive System: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS). Skeletal System: Bone studies. Urinary System: IVP, Cystograms, Percutaneous Nephrolithotomy, Nephrostomy tube placement. Reproductive System: Hysterosalpingograms, Vena spermatica, Cavernography. Various lodine: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography. Respiratory System: Bronchoscopy, Pulmonary biopsies. Circulatory System: Venography, Arteriography, Thrombolytic Therapy, Embolizations, Embolectorny, TVC filter placement, Dilatations, Stent placement.

## Device Story

Multi-functional, tilting C-arm system; floor-mounted stand with integrated tilting patient support table. Supports patient access from both sides. Configured with Philips Optimus generators and Digital Imaging systems. Includes 38 cm multi-mode intensifier, XTV imaging system, collimator with laser cross for positioning, and TV monitors. Used in clinical settings for R/F, fluoroscopy, radiography, and angiography. Operated by healthcare professionals to visualize internal structures; output displayed on TV monitors for diagnostic and interventional guidance.

## Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and compliance with established safety and performance standards.

## Technological Characteristics

Tilting C-arm system; floor-mounted stand; integrated tilting patient support table. Components: Philips Optimus generator, 38 cm multi-mode intensifier, XTV imaging system, collimator with laser cross. Connectivity: ACR/NEMA DICOM standard. Safety: Complies with 21 CFR 1020.30-32, 1040.10, and UL 2601-1.

## Regulatory Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

## Predicate Devices

- Philips MultiDiagnost 4 ([K961374](/device/K961374.md))

## Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the Philips logo, which consists of the word "PHILIPS" in bold, uppercase letters above a shield-like emblem. The emblem features a wavy line across the middle, with a four-pointed star above and below the line. The logo is simple and iconic, representing the brand's identity.

Image /page/0/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 presented in a straightforward, unadorned manner, emphasizing its legibility.

KC23411

# Philips Medical Systems

# 510(k) SUMMARY

The following information is being submitted in accordance with the requirements of 21 CFR 807.92.

| Company Name:<br>Address:         | Philips Medical Systems North America Company<br>22100 Bothell Everett Highway<br>P.O.Box 3003<br>Bothell, WA 98041-3003, USA |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Registration No.:                 | 1217116                                                                                                                       |
| Contact Person:<br>Telephone No.: | Lynn Harmer<br>(425) 487-7312                                                                                                 |
| Date Prepared:                    | September 27, 2002                                                                                                            |
| Device (Trade) Name:              | Philips Multidiagnost Eleva                                                                                                   |
| Classification Name:              | Fluoroscopic X-ray System, 21 CFR 892.1600 class II<br>(90 1ZI)                                                               |

# Predicate Device:

The Philips MultiDiagnost Eleva is substantially equivalent to the Philips MultiDiagnost 4 manufactured by Philips Medical Systems. The Philips MultiDiagnost 4 system received a 510(k) substantially equivalent determination in K961374 on August 19, 1996.

# Device description:

The Philips MultiDiagnost Eleva is a multi-functional, tilting C-arm system consisting of a floor-mounted stand with an integrated tilting patient support table. The table is supported at only one end, allowing patient access from both sides. As a fully integrated system, it can be configured with generators from the Philips Optimus family and Digital Imaging systems. The system comes with a 38 cm multi mode Intensifier, XTV imaging system, collimator with laser cross for patient positioning without x-rays, Philips glass or metal x-ray tubed, and TV monitors.

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#### Indications for Use:

The Philips MultiDiagnost Eleva is intended for the same applications as the previous MultiDiagnost 4 and MultiDiagnost 3 systems. As a multi-functional/universal system. general R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialised interventional applications. This includes the following general areas.

#### Digestive System:

Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS).

#### Skeletal System:

Bone studies.

#### Urinary System:

IVP, Cystograms, Percutaneous Nephrolithotomy, Nephrostomy tube placement.

#### Reproductive System:

Hysterosalpingograms, Vena spermatica, Cavernography.

#### Various lodine:

Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.

#### Respiratory System:

Bronchoscopy, Pulmonary biopsies.

#### Circulatory System:

Venography, Arteriography, Thrombolytic Therapy, Embolizations, Embolectorny, TVC filter placement, Dilatations, Stent placement.

#### 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 and 1040.10
- Underwriters Laboratories Standard for Safety UL 2601-1 and be classified by ● Underwriters Laboratories.
- ACR/NEMA DICOM digital imaging communication standard.

#### Conclusion:

.

The Philips MultDiagnost 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 MultiDiagnost Eleva to be substantially equivalent with the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a logo for the Department of State & Health. The logo is circular and contains an image of an eagle. The eagle is stylized with three lines representing the body and wings. The text "DEPARTMENT OF STATE & HEALTH" is written around the top of the circle.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems North America Company % Michael Kwan, Ph.D. Office Coordinator, 510(k) Review Program Medical Device Services Underwriters Laboratories, Inc. 1655 Scott Blvd. SANTA CLARA CA 95050-4169

### Re: K023441

Trade/Device Name:. Philips Multidiagnost Eleva Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: 90 IZI Dated: October 10, 2002 Received: October 15, 2002

#### Dear Dr. Kwan:

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, Drue, 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.

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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 (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 this 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" (21 CFR Part 807.97). 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

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510(k) Number (if known): Unknown

K023441

Device Name: Philips MultiDiagnost Eleva

Indications for Use:

The MultiDiagnost Eleva is indicated for use in Radiographic/Fluoroscopic, Angiographic, and Interventional diagnostic imaging examinations.

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

David M. Amm

(Division Sign-Off) Division of Reproductive and Radiological D 510(k) Numb

Prescription Use (Per 21 CFR 801.109)

Indications for Use

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