FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8
K Number: K843129
·
Decision Dec 6, 1984
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
71
Applicant Total
61
Review Days
119
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
- SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8
- K Number
- K843129
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2880
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Advanced Technology Laboratories, Inc.
- Date Received
- August 9, 1984
- Decision Date
- December 6, 1984
- Product Code
- JOP
- 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 |
|---|---|---|---|
| JOP | Transducer, Ultrasonic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOP), ordered by most recent decision date.
Falcon/Xpress (Falcon/Xpress)
FDA 510(k)
FDA Class 2
·Cardiovascular
VasoGuard (V10, V8, V6, V4, V2)
FDA 510(k)
FDA Class 2
·Cardiovascular
Smartdop XT6
FDA 510(k)
FDA Class 2
·Cardiovascular
SMARTDOP XT
FDA 510(k)
FDA Class 2
·Cardiovascular
VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING
FDA 510(k)
FDA Class 2
·Cardiovascular
FALCON
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |