FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
K Number: K903348
·
Decision Oct 22, 1990
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
35
Applicant Total
61
Review Days
88
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Basic Information
- Device Name
- ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
- K Number
- K903348
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2960
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Advanced Technology Laboratories, Inc.
- Date Received
- July 26, 1990
- Decision Date
- October 22, 1990
- Product Code
- HGL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HGL | Transducer, Ultrasonic, Obstetric | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HGL), ordered by most recent decision date.
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MER MULTIPLANE VAGINAL PROBE (MVP)
FDA 510(k)
FDA Class 2
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Other Clearances by Advanced Technology Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021966 | Q LAB SOFTWARE | Jul 2, 2002 | Substantially Equivalent |
| K011224 | HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY | May 4, 2001 | Substantially Equivalent |
| 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 |
| K905248 | NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS | Feb 28, 1991 | Substantially Equivalent |
| K903603 | ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9) | Feb 26, 1991 | Substantially Equivalent |