FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER
K Number: K951141
·
Decision May 30, 1995
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
54
Applicant Total
2
Review Days
78
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Basic Information
- Device Name
- STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER
- K Number
- K951141
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2010
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Star Technologies, Inc.
- Date Received
- March 13, 1995
- Decision Date
- May 30, 1995
- Product Code
- LMB
- 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 |
|---|---|---|---|
| LMB | Device, Digital Image Storage, Radiological | FDA class 1 | Radiology |
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Other Clearances by Star Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952914 | STAR TECHNOLOGIES, INC. FILM IMAGE SCAN SYSTEM | Sep 18, 1995 | Substantially Equivalent |