510(k) K942558
- Device
- Instacine
- Applicant
- FIDELITY MEDICAL, INC.
- 510(k) number
- K942558
- Product code
- LMB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-05-30
- Date received
- 1994-05-31
- Regulation
- 892.2010
- Classification name
- Device, Digital Image Storage, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONEN GANS
- Address
- 6 Vreeland Rd. Florham Park NJ US 07932 07932
FDA Registration Numbers#
- 3011580044
- 2184007
- 2518897
- 3008347129
- 3021023132
- 1066247
- 3038614464
- 3009219448
- 9610612
- 3009717300
- 3018050916
- 3007457520
- 1320894
- 3017697447
- 3030516433
- 2916714
- 3010326005
- 3004915908
- 1063008
- 3007137598
- 3004363352
- 1647172
- 1320925
- 3003790304
- 3011215096
- 2954921
- 3004158384
- 8043980
- 3004091527
- 3004722076
- 3003895711
- 3016527960
- 3005439497
- 3009831823
- 3011344631
- 3010864832
- 3033043422
- 3004989804
- 3014945378
- 3005635368
- 3010583458
- 3000237660
- 1643264
- 3005205318
- 2936485
- 3004730352
- 3002304283
- 3003604053
- 3009341091
- 3011936016
- 3014991167
- 3004026651
- 3043496873
- 3043648115
- 3007142723
- 3014232530
- 3005083075
- 3002807616
- 1530958
- 1000263389
- 1000181430
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LMB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992131 | SAMSUNG RAYPAX LONG TERM ARCHIVE | Samsung Sds Co., Ltd. | 1999-09-13 |
| K984405 | ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 | Intracom Corp. | 1999-02-08 |
| K983447 | WISE (II) IMAGE MANAGEMENT SYSTEM | Sectra-Imtec AB | 1998-10-29 |
| K980243 | PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) | Parameter Developments, Inc. | 1998-04-03 |
| K973463 | OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE | O Tech, Inc. | 1997-12-02 |
| K973413 | ID. STORE (RELEASE 2.0) | I.S.G. Technologies, Inc. | 1997-11-25 |
| K972380 | KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) | Eastman Kodak Company | 1997-09-11 |
| K971848 | TDK MEDICAL GRADE CD-R | Tdk Electronics Corporation of America | 1997-08-15 |
| K971451 | WISE IMAGE MANAGEMENT SYSTEM | O Tech, Inc. | 1997-06-26 |
| K963936 | ACCESSPOINT, MED E-MAIL, DICOM READER | Biosound, Inc. | 1997-03-31 |
| K964803 | UNIVISION ECHOCARDIOLOGY SYSTEM | Network Concepts, Inc. | 1997-02-11 |
| K964274 | WRITESTAR, AND VIEWSTAR | Comview Corp. | 1997-01-10 |
| K963395 | IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM | Sectra-Imtec AB | 1996-10-25 |
| K961680 | SONY DKR-700 DIGITAL STILL RECORDER | Sony Medical Systems | 1996-07-03 |
| K961160 | UPACS VERSION 1.7 | Base Ten Systems, Inc. | 1996-06-11 |