FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESUBMITTAL OF MI 1000C MICROIMAGER
K Number: K881979
·
Decision Jun 12, 1989
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
71
Applicant Total
27
Review Days
396
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
- RESUBMITTAL OF MI 1000C MICROIMAGER
- K Number
- K881979
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2880
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Ausonics Pty , Ltd.
- Date Received
- May 12, 1988
- Decision Date
- June 12, 1989
- 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 Ausonics Pty , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K933916 | AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER | Oct 3, 1994 | Substantially Equivalent |
| K915715 | CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER | Jul 2, 1992 | Substantially Equivalent |
| K920307 | AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION | May 19, 1992 | Substantially Equivalent |
| K905488 | DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN | Dec 18, 1991 | Substantially Equivalent |
| K902728 | 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) | Feb 13, 1991 | Substantially Equivalent |
| K896714 | AUSONICS 5000 | Jun 11, 1990 | Substantially Equivalent |
| K884299 | APA-C CATALOG NUMBER A-8001-C | Jan 10, 1989 | Substantially Equivalent |
| K883925 | UROIMAGER | Dec 15, 1988 | Substantially Equivalent |
| K883079 | WWDS-005 HUMAN RECTAL PROBE | Dec 14, 1988 | Substantially Equivalent |
| K883372 | ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT | Nov 25, 1988 | Substantially Equivalent |