Philips Easy Diagnost
FDA 510(k) K970640 · Philips Medical Systems North America, Inc.
510(k) numberK970640
Submission
- Device name
- Philips Easy Diagnost
- Applicant
- Philips Medical Systems North America, Inc.
Shelton, CT, US - Received
- February 20, 1997
- Decision date
- March 21, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IXR
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|---|---|---|---|
| K000412 | Vision R/F Tilting TableIXR · Traditional | Villa Sistemi Medicali S.P.A. | 04/24/2000SE |
| K973039 | Legacy/Legacy-D TableIXR · Traditional | GE Medical Systems | 10/16/1997SE |
| K971128 | CAP-35B Iii/Cine 275IXR · Traditional | Jamieson Film Co. | 04/28/1997SE |
| K965105 | Electrophysiology Tilt Table Model #9660IXR · Traditional | U.S. Imaging Tables, Inc. | 01/30/1997SE |
| K965096 | Fluoroview Series Fluoroscopic TablesIXR · Traditional | U.S. Imaging Tables, Inc. | 01/27/1997SE |
| K963851 | Tilting Radiographic Table (Remote)IXR · Traditional | Acoma Medical Imaging, Inc. | 01/23/1997SE |
| K961022 | Tangent Vi TableIXR · Traditional | Fischer Imaging Corp. | 05/03/1996SE |
| K954356 | Compax 90/15EIXR · Traditional | General Electric Co. | 10/07/1995SE |
| K953557 | Surgical C-Arm Table, 9610IXR · Traditional | U.S. Imaging Tables, Inc. | 09/26/1995SE |
| K953556 | Vacs Table, 9650IXR · Traditional | U.S. Imaging Tables, Inc. | 09/26/1995SE |
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| 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 Philips Easy Diagnost cleared by the FDA?
Philips Easy Diagnost (K970640) received a 510(k) decision of Substantially Equivalent on March 21, 1997, 29 days after the submission was received.
What is the product code of K970640?
The FDA product code is IXR – Table, Radiographic, Tilting, a Class II (moderate risk) device regulated under 21 CFR 892.1980.