FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS
K Number: K905248
·
Decision Feb 28, 1991
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
61
Review Days
99
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Basic Information
- Device Name
- NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS
- K Number
- K905248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Advanced Technology Laboratories, Inc.
- Date Received
- November 21, 1990
- Decision Date
- February 28, 1991
- Product Code
- DQK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K002144 | MEDLINK DIAGNOSTIC OFFLINE WORKSTATION | Sep 28, 2000 | Substantially Equivalent |
| K992470 | ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM | Aug 23, 1999 | Substantially Equivalent |
| K991671 | HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM | Jun 18, 1999 | Substantially Equivalent |
| K961459 | LEVEL 10 HDI | Mar 26, 1997 | Substantially Equivalent |
| K935009 | PEGASUS | Oct 11, 1994 | Substantially Equivalent |
| K940423 | NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE | Jul 29, 1994 | Substantially Equivalent |
| K903603 | ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9) | Feb 26, 1991 | Substantially Equivalent |
| K901329 | CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEM | Nov 23, 1990 | Substantially Equivalent |