FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANGIOTEC IMAGE MANAGEMENT SYSTEM
K Number: K903806
·
Decision Nov 23, 1990
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
54
Applicant Total
5
Review Days
95
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Basic Information
- Device Name
- ANGIOTEC IMAGE MANAGEMENT SYSTEM
- K Number
- K903806
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2010
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Andros Analyzers, Inc.
- Date Received
- August 20, 1990
- Decision Date
- November 23, 1990
- 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 Andros Analyzers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K893476 | ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV. | Jun 23, 1989 | Substantially Equivalent |
| K892869 | ANGIOTEC ZX DIGITAL IMAGE PROCESSOR | May 26, 1989 | Substantially Equivalent |
| K891485 | ANGIOTEC FMX-2220 SYSTEM | May 5, 1989 | Substantially Equivalent |
| K852463 | ANDROS ANALYZERS AIRWAY ADAPTER | Jul 8, 1985 | Substantially Equivalent |