Company
Philips Medical Systems Sales & Service Region No. America
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
26recalls (0 in 12 months)
18recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KPR | System, X-Ray, Stationary | 6 |
| IZL | System, X-Ray, Mobile | 5 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 3 |
| LLZ | System, Image Processing, Radiological | 3 |
| IZI | System, X-Ray, Angiographic | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 |
| KPS | System, Tomography, Computed, Emission | 1 |
| KRP | Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal | 1 |
| LMB | Device, Digital Image Storage, Radiological | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2005 | Philips Medical Systems Sales & Service Region No. America Easy Access Image Management System with CL.Net. Terminated |
LMB | K983447 |
| Apr 6, 2005 | Philips Medical Systems Sales & Service Region No. America Tomoscan Terminated |
KPS | None listed |
| Mar 18, 2005 | Philips Medical Systems Sales & Service Region No. America Xcelera R1.2 Cardiology image and information management solution software. Terminated |
LLZ | K022788 |
| Dec 24, 2004 | Philips Medical Systems Sales & Service Region No. America Thoravision II Thorax and Mass Chest Column. Part numbers 4512 130 07812. Terminated |
KPR | None listed |
| Dec 24, 2004 | Philips Medical Systems Sales & Service Region No. America Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811 Terminated |
KPR | K931071 K981657 |
| Sep 29, 2004 | Philips Medical Systems Sales & Service Region No. America NT Intera Magnetic Resonance Image System Terminated |
KRP | K001796 |
| Sep 15, 2004 | Philips Medical Systems Sales & Service Region No. America BV212 Mobile X-Ray System Terminated |
IZL | K910115 |
| Sep 15, 2004 | Philips Medical Systems Sales & Service Region No. America BV29 Mobile X-Ray System Terminated |
IZL | K910115 |
| Sep 15, 2004 | Philips Medical Systems Sales & Service Region No. America BV26 Mobile X-Ray System Terminated |
IZL | K921255 |
| Sep 15, 2004 | Philips Medical Systems Sales & Service Region No. America BV 25 Gold Mobile X-Ray System Terminated |
IZL | K921255 |
| Sep 15, 2004 | Philips Medical Systems Sales & Service Region No. America BV25 Mobile X-Ray System Terminated |
IZL | K910115 |
| Aug 4, 2004 | Philips Medical Systems Sales & Service Region No. America ViewForum Review Station
Part Numbers: 9896 507 71830, 9896 507 71831, and 9896 507 71832. Terminated |
LLZ | None listed |
| Aug 4, 2004 | Philips Medical Systems Sales & Service Region No. America MultiDiagnost Eleva
Part Numbers: 9896 001 41501 and 9896 001 41502 Terminated |
IZI | None listed |
| Aug 4, 2004 | Philips Medical Systems Sales & Service Region No. America EasyDiagnost Eleva
Part Number 989605071921 Terminated |
KPR | None listed |
| Jul 20, 2004 | Philips Medical Systems Sales & Service Region No. America Trolley for Intera/NT MRI System Terminated |
LNH | None listed |
| Jul 20, 2004 | Philips Medical Systems Sales & Service Region No. America Xcelera System, image processing, radiological. Terminated |
LLZ | K022788 |
| Jul 20, 2004 | Philips Medical Systems Sales & Service Region No. America Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C Terminated |
EHD | K971365 |
| Jul 20, 2004 | Philips Medical Systems Sales & Service Region No. America Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems. Terminated |
IZI | K912470 K923813 |
| Jul 20, 2004 | Philips Medical Systems Sales & Service Region No. America Diagnost 97 Terminated |
K912470 | |
| Jul 20, 2004 | Philips Medical Systems Sales & Service Region No. America OmniDiagnost System Terminated |
K982993 | |
| Dec 24, 2003 | Philips Medical Systems Sales & Service Region No. America Philips Digital Diagnost VT Terminated |
KPR | None listed |
| Dec 24, 2003 | Philips Medical Systems Sales & Service Region No. America Digital Diagnost VE Terminated |
KPR | None listed |
| Dec 24, 2003 | Philips Medical Systems Sales & Service Region No. America Bucky Diagnost FS Part number 9890-010-83651 Terminated |
KPR | K945278 |
| Sep 11, 2003 | Philips Medical Systems Sales & Service Region No. America Diagnost 94 Terminated |
IZZ | K912470 |
| Sep 11, 2003 | Philips Medical Systems Sales & Service Region No. America Diagnost 97 Terminated |
IZZ | K912470 |
| Sep 11, 2003 | Philips Medical Systems Sales & Service Region No. America Diagnost 96 Terminated |
IZZ | K912470 |