PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)
FDA 510(k) clearance K980243 · decided 1998-04-03
Clearance details
- K-number
- K980243
- Device name
- PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)
- Applicant
- Parameter Developments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-23
- Decision date
- 1998-04-03
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- LMB
- Device class
- 1
- Regulation number
- 892.2010
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- San Leandro, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SAMSUNG RAYPAX LONG TERM ARCHIVE (K992131) | Samsung Sds Co., Ltd. | 1999-09-13 |
| ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 (K984405) | Intracom Corp. | 1999-02-08 |
| WISE (II) IMAGE MANAGEMENT SYSTEM (K983447) | Sectra-Imtec AB | 1998-10-29 |
| OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE (K973463) | O Tech, Inc. | 1997-12-02 |
| ID. STORE (RELEASE 2.0) (K973413) | I.S.G. Technologies, Inc. | 1997-11-25 |
| KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) (K972380) | Eastman Kodak Company | 1997-09-11 |
| TDK MEDICAL GRADE CD-R (K971848) | Tdk Electronics Corporation of America | 1997-08-15 |
| WISE IMAGE MANAGEMENT SYSTEM (K971451) | O Tech, Inc. | 1997-06-26 |
| ACCESSPOINT, MED E-MAIL, DICOM READER (K963936) | Biosound, Inc. | 1997-03-31 |
| UNIVISION ECHOCARDIOLOGY SYSTEM (K964803) | Network Concepts, Inc. | 1997-02-11 |
| WRITESTAR, AND VIEWSTAR (K964274) | Comview Corp. | 1997-01-10 |
| IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM (K963395) | Sectra-Imtec AB | 1996-10-25 |
Recalls involving this device
No recalls on record reference this clearance.