510(k) K955000
- Device
- REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE
- Applicant
- CERNER CORP.
- 510(k) number
- K955000
- Product code
- LMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-01-26
- Date received
- 1995-11-01
- Regulation
- 892.2020
- Classification name
- System, Digital Image Communications, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL A HELMUT
- Address
- 2800 Rockcreek Pkwy. Kansas City MO US 64117 64117
FDA Registration Numbers#
- 3009717300
- 3011623994
- 3015316279
- 3003032840
- 9610617
- 3017435704
- 3018133052
- 3016750628
- 3004120479
- 3011813678
- 2954921
- 1526350
- 3011713193
- 1626313
- 3036471119
- 3013757696
- 3026970882
- 3015341893
- 3021336392
- 3011543740
- 2134213
- 1530958
- 3023245
- 3014937484
- 3015173173
- 3018069403
- 3009028104
- 3009746052
- 1825014
- 3014432311
- 3005517190
- 2027009
- 3012624817
- 3033527273
- 9613188
- 3030179922
- 3004091527
- 3015537315
- 3021233709
- 3012272052
- 1066247
- 3015168749
- 3010956703
- 3029937167
- 3017058304
- 3038177848
- 9610773
- 3019216
- 3042278786
- 2518897
- 3020521079
- 3012453401
- 3030446846
- 3013427569
- 3011408182
- 3004730352
- 3010400367
- 3007457520
- 3019544554
- 3002821232
- 3018733944
- 3010331645
- 1317188
- 3024137003
- 1937397
- 1000602763
- 3006619220
- 3016110967
- 3014116171
- 3043237444
- 3036039341
- 3000237660
- 3004722076
- 3044622440
- 1223864
- 9710645
- 3007867472
- 3009831823
- 1063008
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LMD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K994329 | IIVS INTEGRATED IMAGE VIEWING STATION | Terarecon,Inc. | 2000-05-26 |
| K992698 | STENTOR, PAGEVIEW | Stentor, Inc. | 1999-10-25 |
| K992426 | RAYPAX WEB CLINICAL SYSTEM | Samsung Sds Co., Ltd. | 1999-10-13 |
| K992352 | ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 | Inteleradiology, Inc. | 1999-09-29 |
| K991537 | SAMSUNG RAYPAX SYSTEM | Samsung Sds Co., Ltd. | 1999-07-06 |
| K984000 | STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM | Surgical Navigation Technologies, Inc. | 1999-01-12 |
| K974707 | IMAGEQUEST | Visual Med, Inc. | 1998-07-31 |
| K981053 | KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW | Eastman Kodak Company | 1998-06-18 |
| K980918 | JPACS | Philips Medical Systems (Cleveland), Inc. | 1998-06-03 |
| K974882 | DOWNSCAN LT | Merlin Engineering Works, Inc. | 1998-05-22 |
| K980684 | VR NETSERVE | I.S.G. Technologies, Inc. | 1998-05-06 |
| K980541 | BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY | Barco NV Display Systems | 1998-04-09 |
| K980241 | NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE | Netco Communications Corp. | 1998-03-17 |
| K980220 | IISYS PACS SYSTEM | Sterling Diagnostic Imaging, Inc. | 1998-02-13 |
| K974130 | VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE | Dejarnette Research Systems | 1998-01-29 |
Legacy Summary#
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FDA Review#
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