Cerner Corporation
Kansas City, MO, US
Cerner Corporation appears in FDA device records in Kansas City, MO. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Cerner Corporation between 1996 and 2015. The busiest year on record is 2009, with 3. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 2000 | 1 |
| 2007 | 1 |
| 2009 | 3 |
| 2012 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K151672 | Cerner CareAware Event Management | MSX | Substantially Equivalent | |
| K121758 | CERNER FETALINK+(VERSION1.0) | HGM | Substantially Equivalent | |
| K093134 | CERNER CAREAWARE IBUS | DRG | Substantially Equivalent | |
| K091251 | CERNER FETALINK (VERSION 1.0) | HGM | Substantially Equivalent | |
| K091032 | CERNER PROVISION WORKSTATION (VERSION 2.5) | LLZ | Substantially Equivalent | |
| K070394 | CERNER PROVISION WORKSTATION | LLZ | Substantially Equivalent | |
| K000770 | PROVIEW MEDICAL IMAGE DISPLAY MODULE | LLZ | Substantially Equivalent | |
| K955000 | REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE | LMD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013546957 | 3013546957 | Cerner Corporation | 8779 Hillcrest Rd, Kansas City, MO 64138 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MMHBlood Establishment Computer Software And Accessories
- KMIMonitor, Bed Patient
- LMDSystem, Digital Image Communications, Radiological
- LLZSystem, Image Processing, Radiological
- HGMSystem, Monitoring, Perinatal
- MSXSystem, Network And Communication, Physiological Monitors
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1236-2009 | Cerner Bridge Medical Transfusion Administration and Specimen Collections, Versions 3.4.0, 3.4.1 and 3.4.2. | Specimen labels printing incorrect patient demographics. | Terminated | ||
| Z-1243-2007 | Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities. | Defects in the Auto Launch functionality make it possible for a mismatch of patient data. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain