FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMEX 8000 PERSONAL CASCULAR LAB
K Number: K942243
·
Decision Nov 3, 1995
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
19
Review Days
543
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
- IMEX 8000 PERSONAL CASCULAR LAB
- K Number
- K942243
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imex Medical Systems, Inc.
- Date Received
- May 9, 1994
- Decision Date
- November 3, 1995
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYO), ordered by most recent decision date.
ARTHUR
FDA 510(k)
FDA Class 2
·Radiology
EdgeFlow UW20
FDA 510(k)
FDA Class 2
·Radiology
Accuro XV
FDA 510(k)
FDA Class 2
·Radiology
QT Scanner 2000 Model A
FDA 510(k)
FDA Class 2
·Radiology
IntraSight Plus
FDA 510(k)
FDA Class 2
·Radiology
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Imex Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973556 | IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000 | Apr 24, 1998 | Substantially Equivalent |
| K973562 | IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100 | Apr 15, 1998 | Substantially Equivalent |
| K973336 | IMEX STETHODOP | Feb 5, 1998 | Substantially Equivalent |
| K970156 | IMEX FUTURALDOP PRO | Apr 4, 1997 | Substantially Equivalent |
| K944196 | IMWXDOP IR | May 12, 1995 | Substantially Equivalent |
| K942441 | IMEXDOP CT+ | Aug 23, 1994 | Substantially Equivalent |
| K910462 | POCKET DOP 3 | Jun 24, 1991 | Substantially Equivalent |
| K901593 | IMEX DOP-TONE II | Jul 2, 1990 | Substantially Equivalent |
| K896613 | FLAT VASCULAR PROBE | Feb 16, 1990 | Substantially Equivalent |
| K882138 | IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER | Nov 7, 1988 | Substantially Equivalent |