Intellivue Clinical Information Portfolio
FDA 510(k) K100272 · Philips Medical Systems
510(k) numberK100272
Submission
- Device name
- Intellivue Clinical Information Portfolio
- Applicant
- Philips Medical Systems
Andover, MA, US - Received
- January 29, 2010
- Decision date
- April 14, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
Other 510(k)s with product code DXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212003 | ESSENZ Patient MonitorDXJ · Special | Livanova Deutschland, GmbH | 11/10/2021SE |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X)DXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 09/30/2021SE |
| K201162 | Essence 55SP Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 08/27/2020SE |
| K173107 | Vios Central Station Monitor Software, Vios Central Server SoftwareDXJ · Traditional | Vios Medical, Inc. | 07/26/2018SE |
| K180534 | Philips IntelliVue GuardianSoftwareDXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 07/16/2018SE |
| K173381 | Nexxis ORDXJ · Special | Barco N.V. | 02/22/2018SE |
| K172969 | Essence 55S Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 01/26/2018SE |
| K170460 | Sorin ConnectDXJ · Special | Sorin Group Deutschland GmbH | 06/08/2017SE |
| K170537 | Nexxis OR, NexxisDXJ · Special | Barco N.V. | 04/21/2017SE |
| K161880 | NIVR58-T kitDXJ · Special | Barco N.V. | 03/14/2017SE |
More from Barco N.V.
| 510(k) | Device | Decision |
|---|---|---|
| K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemIYN · Traditional | 09/24/2021SE |
| K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN · Traditional | 09/08/2021SE |
| K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50…DPS · Special | 06/30/2021SE |
| K191738 | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph…DPS · Traditional | 09/29/2020SE |
| K192875 | Philips Biosensor BX100DRG · Traditional | 04/16/2020SE |
| K183387 | M3290B Patient Information Center iXMHX · Traditional | 08/06/2019SE |
| K180017 | MX40 Release C.01MHX · Special | 07/24/2018SE |
| K172226 | MX40 Release B.07MHX · Traditional | 11/09/2017SE |
| K163584 | M3290B Philips IntelliVue Information Center iXMHX · Traditional | 07/07/2017SE |
| K163649 | SureSigns VS3; SureSigns VS4DSJ · Special | 03/31/2017SE |
Questions and answers
When was Intellivue Clinical Information Portfolio cleared by the FDA?
Intellivue Clinical Information Portfolio (K100272) received a 510(k) decision of Substantially Equivalent on April 14, 2010, 75 days after the submission was received.
What is the product code of K100272?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.