FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000
K Number: K973556
·
Decision Apr 24, 1998
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
19
Review Days
217
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Basic Information
- Device Name
- IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000
- K Number
- K973556
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Imex Medical Systems, Inc.
- Date Received
- September 19, 1997
- Decision Date
- April 24, 1998
- Product Code
- IYN
- 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Imex Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K942243 | IMEX 8000 PERSONAL CASCULAR LAB | Nov 3, 1995 | 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 |