FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
K Number: K984000
·
Decision Jan 12, 1999
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
27
Review Days
63
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
- K Number
- K984000
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgical Navigation Technologies, Inc.
- Date Received
- November 10, 1998
- Decision Date
- January 12, 1999
- Product Code
- LMD
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LMD), ordered by most recent decision date.
IIVS INTEGRATED IMAGE VIEWING STATION
FDA 510(k)
FDA Class 1
·Radiology
STENTOR, PAGEVIEW
FDA 510(k)
FDA Class 1
·Radiology
RAYPAX WEB CLINICAL SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
FDA 510(k)
FDA Class 1
·Radiology
SAMSUNG RAYPAX SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
IMAGEQUEST
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by Surgical Navigation Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K000246 | RADIOCAMERAS EXTRACRANIAL SYSTEM | Oct 20, 2000 | Substantially Equivalent |
| K994355 | RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION | Mar 22, 2000 | Substantially Equivalent |
| K992461 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Feb 22, 2000 | Substantially Equivalent |
| K992927 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Dec 29, 1999 | Substantially Equivalent |
| K993021 | METRX SYSTEM | Nov 10, 1999 | Substantially Equivalent |
| K992354 | SNT IMAGE ANALYSIS SYSTEM | Oct 12, 1999 | Substantially Equivalent |
| K991468 | IMMERGE IMAGE CORRELATION | Jul 6, 1999 | Substantially Equivalent |
| K990214 | FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM | Apr 22, 1999 | Substantially Equivalent |
| K983670 | STEALTHSTATION SYSTEM | Jan 14, 1999 | Substantially Equivalent |
| K983397 | STEALTHSTATION TREATMENT GUIDANCE PLAFFORM | Dec 4, 1998 | Substantially Equivalent |