FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDRA VIEW IMAGING SYSTEM
K Number: K901323
·
Decision Apr 25, 1990
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
27
Review Days
35
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Basic Information
- Device Name
- HYDRA VIEW IMAGING SYSTEM
- K Number
- K901323
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Mallinckrodt Group, Inc.
- Date Received
- March 21, 1990
- Decision Date
- April 25, 1990
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
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Other Clearances by Mallinckrodt Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945053 | LF CT HIG PRESSURE CATHETERS | May 19, 1995 | Substantially Equivalent |
| K945140 | URO-FLO | Mar 8, 1995 | Substantially Equivalent |
| K943581 | HYDRADJUST IV UROLOGICAL TABLE | Jan 4, 1995 | Substantially Equivalent |
| K943122 | SURGICAL DRAPES | Sep 7, 1994 | Substantially Equivalent |
| K934664 | HYDRAGOWN | May 24, 1994 | Substantially Equivalent |
| K920742 | HYDRAJUST IV UROLOGICAL TABLE | Apr 27, 1992 | Substantially Equivalent |
| K912944 | CT 8000 DIGITAL INJECTION SYSTEM | Feb 4, 1992 | Substantially Equivalent |
| K913264 | HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE | Nov 1, 1991 | Substantially Equivalent |
| K905789 | FRANKLIN 9000 WALL STAND | May 20, 1991 | Substantially Equivalent |
| K904147 | HUGH YOUNG II UROLOGICAL X-RAY SYSTEM | Dec 13, 1990 | Substantially Equivalent |