FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN
K Number: K905488
·
Decision Dec 18, 1991
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
54
Applicant Total
27
Review Days
376
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Basic Information
- Device Name
- DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN
- K Number
- K905488
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2010
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Ausonics Pty , Ltd.
- Date Received
- December 7, 1990
- Decision Date
- December 18, 1991
- Product Code
- LMB
- 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 |
|---|---|---|---|
| LMB | Device, Digital Image Storage, Radiological | FDA class 1 | Radiology |
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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 |
| 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 |
| K881979 | RESUBMITTAL OF MI 1000C MICROIMAGER | Jun 12, 1989 | 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 |