510(k) K972925
- Device
- ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC
- Applicant
- ACCESS RADIOLOGY CORP.
- 510(k) number
- K972925
- Product code
- LMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-12-05
- Date received
- 1997-08-08
- 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
- ALLAN M GREEN
- Address
- One Financial Center Boston MA US 02111 02111
FDA Registration Numbers#
- 3009028104
- 2184007
- 3021233709
- 1066247
- 3003989064
- 3019544554
- 3033527273
- 3010601176
- 9613188
- 1125622
- 9610612
- 3015316279
- 3011373951
- 3006615210
- 1526350
- 3029916061
- 3011569539
- 2952596
- 8041160
- 3015173173
- 1825014
- 3026970882
- 3004722076
- 3017487805
- 8043933
- 3019269298
- 3012373810
- 3014945378
- 1937397
- 3010400367
- 3015341893
- 3016750628
- 3030446846
- 1626313
- 3010202439
- 2936485
- 3012453401
- 3014991167
- 3010331645
- 3015537315
- 3017435704
- 3035383301
- 3006973644
- 1000181154
- 3016527960
- 3027502679
- 3007817002
- 3022435840
- 3036039341
- 3010956703
- 3014146081
- 3024137003
- 3029937167
- 2134213
- 3008027912
- 3003790304
- 9610773
- 2954921
- 2320618
- 3010043098
- 3014937484
- 3009132733
- 3004091527
- 3005439497
- 3009831823
- 3036471119
- 3005517190
- 3009746052
- 3000237660
- 1000602763
- 3030228575
- 9710645
- 3017058304
- 3004120479
- 9615010
- 3023245
- 3044622440
- 3036833001
- 3042278786
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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