Philips IntelliVue GuardianSoftware
FDA 510(k) K180534 · Philips Medizin Systeme Boeblingen GmbH
510(k) numberK180534
Submission
- Device name
- Philips IntelliVue GuardianSoftware
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
Boeblingen, DE - Received
- February 28, 2018
- Decision date
- July 16, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
| K161767 | Philips IntelliVue GuardianSoftwareDXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 01/27/2017SE |
More from Philips Medizin Systeme Boeblingen GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…MHX · Traditional | 02/06/2026SE |
| K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550MHX · Traditional | 10/17/2025SE |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…HGM · Traditional | 07/02/2024SE |
| K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…MHX · Traditional | 12/19/2023SE |
| K230604 | IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)MHX · Traditional | 11/22/2023SE |
| K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…MHX · Traditional | 08/22/2023SE |
| K210906 | IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…MHX · Traditional | 10/07/2021SE |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X)DXJ · Traditional | 09/30/2021SE |
| K192137 | IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550MHX · Abbreviated | 09/11/2020SE |
| K182979 | IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…MHX · Special | 11/19/2019SE |
Questions and answers
When was Philips IntelliVue GuardianSoftware cleared by the FDA?
Philips IntelliVue GuardianSoftware (K180534) received a 510(k) decision of Substantially Equivalent on July 16, 2018, 138 days after the submission was received.
What is the product code of K180534?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.