Practix Convenio
FDA 510(k) K042368 · Philips Medical Systems North America Co.
510(k) numberK042368
Submission
- Device name
- Practix Convenio
- Applicant
- Philips Medical Systems North America Co.
Bothell, WA, US - Received
- August 31, 2004
- Decision date
- October 4, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260236 | XliteIZL · Traditional | Gemss Healthcare Co., Ltd. | 08/03/2026SE |
| K253058 | Portable DR Imaging SystemIZL · Traditional | Shantou Institute of Ultrasonic Instruments Co.… | 06/18/2026SE |
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO)IZL · Traditional | DRGEM Corporation | 05/14/2026SE |
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemIZL · Traditional | Carestream Health | 03/11/2026SE |
| K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)IZL · Traditional | Poskom Co., Ltd. | 02/23/2026SE |
| K250976 | Airbile-100IZL · Traditional | Poskom Co., Ltd. | 12/19/2025SE |
| K251710 | Mobile X-ray unit (!M1)IZL · Traditional | Solutions For Tomorrow AB | 10/24/2025SE |
| K243864 | BONX805IZL · Traditional | Bontech Co., Ltd. | 09/12/2025SE |
| K251443 | PromoIZL · Traditional | DRGEM Corporation | 08/22/2025SE |
| K251223 | HnX-P1, HnX-PBIZL · Traditional | H&abyz Co., Ltd. | 08/04/2025SE |
More from H&abyz Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K101311 | Ep Navigator R3LLZ · Traditional | 09/30/2010SE |
| K102005 | Allura Xper or Table SeriesOWB · Traditional | 08/09/2010SE |
| K090625 | Wireless Portable Detector FD-W17MQB · Traditional | 03/24/2009SE |
| K090590 | Veradius, Model 718-130OWB · Traditional | 03/16/2009SE |
| K082280 | Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital…MHX · Special | 10/08/2008SE |
| K063781 | Philips Xd-S Direct Radiography Workstation/PackageLLZ · Traditional | 01/05/2007SE |
| K062233 | Heartstart MRX Monitor/DefibrillatorMKJ · Special | 11/22/2006SE |
| K062268 | Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03DQA · Special | 10/18/2006SE |
| K062283 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsMHX · Special | 09/20/2006SE |
| K061685 | PulseraIZL · Traditional | 09/15/2006SE |
Questions and answers
When was Practix Convenio cleared by the FDA?
Practix Convenio (K042368) received a 510(k) decision of Substantially Equivalent on October 4, 2004, 34 days after the submission was received.
What is the product code of K042368?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.