PHILIPS INTEGRIS H5000
K971365 · Philips Medical Systems North America, Inc. · IZI · May 14, 1997 · Radiology
Device Facts
| Record ID | K971365 |
|---|
| Device Name | PHILIPS INTEGRIS H5000 |
|---|
| Applicant | Philips Medical Systems North America, Inc. |
|---|
| Product Code | IZI · Radiology |
|---|
| Decision Date | May 14, 1997 |
|---|
| Decision | SESE |
|---|
| Submission Type | Traditional |
|---|
| Regulation | 21 CFR 892.1600 |
|---|
| Device Class | Class 2 |
|---|
Device Story
Integris H 5000 and BH 5000 are cardio/vascular imaging systems. Used in clinical settings for diagnostic and interventional procedures. Systems acquire X-ray images for visualization of cardiovascular and vascular structures. Operated by trained medical professionals. Output provided to clinicians for diagnostic assessment and procedural guidance. Benefit includes enhanced visualization of anatomy to support clinical decision-making during cardiovascular and vascular interventions.
Clinical Evidence
No clinical data provided; reliance on past experience with substantially equivalent predicate devices and compliance with safety standards.
Technological Characteristics
Cardio/vascular X-ray imaging system. Manufactured per UL 187 and UL 2601 safety standards. Subject to 21CFR part 1000 Federal Performance Standards.
Regulatory Classification
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.
Related Devices
- K984545 — RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS · Philips Medical Systems North America, Inc. · Feb 25, 1999
- K032443 — DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE · Shimadzu Corp. · Feb 20, 2004
- K024200 — INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION) · Ge Medical Systems, Inc. · Jan 16, 2003
- K991922 — DIGITAL IMAGING SYSTEM (BSR) · Siemens Medical Solutions USA, Inc. · Sep 1, 1999
- K181830 — Azurion R2.0 · Philips Medical Systems Nederland B.V. · Aug 2, 2018
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the Philips logo, which consists of the word "PHILIPS" in a bold, sans-serif font above a shield-like emblem. The emblem features a circle with two wavy lines across the middle, resembling water or sound waves. Above and below the wavy lines are four-pointed stars, adding a celestial or technological element to the design.
MAY 1 4 1997
Image /page/0/Picture/1 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 text appears to be a logo or brand name.
## Philips Medical Systems
P.O. Box 10000, 5680 DA Best, The Netherlands Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section.
> TOM XRD Best XDB087-970107/RR/TT
1997.02.25
## SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
for
## PHILIPS INTEGRIS H 5000 and BH 5000 CARDIO / VASCULAR SYSTEMS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
The undersigned certifies that the 510(k) Pre-Market notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence.
This information and data is summarized as follows:
- 1. The Integris H 5000 / BH 5000 systems are subject to Federal Performance Standards, defined in 21CFR - part 1000;
- 2. The Integris H5000 / BH 5000 systems will be manufactured in accordance with voluntary safety standards, such as UL 187 and UL 2601;
- 3. The information for Users contains comprehensive information to insure safe and effective use;
- 4. Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when used as directed in the Information for Users.
**Ing. R.W.Rijntjes**
Approbation manager
Approbation manager Quality Assurance dept. XSB / XCB Philips Medical Systems Nederland BV Best, The Netherlands.
522 104 2893
