Catheterization Table KS-60
FDA 510(k) K951315 · Shimadzu Medical Systems
510(k) numberK951315
Submission
- Device name
- Catheterization Table KS-60
- Applicant
- Shimadzu Medical Systems
Torrance, CA, US - Received
- March 23, 1995
- Decision date
- May 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K921501 | Deluxe C Arm Radiological Table, Model #056-004IZZ · Traditional | Biodan Medical Systems, Ltd. | 05/15/1992SE |
| K920732 | Catherization KS-50IZZ · Traditional | Shimadzu Medical Systems | 04/16/1992SE |
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| K071291 | Echoview / Shimasonic Diagnostic Ultrasound System, Model SDU-1100ITX · Traditional | 01/09/2008SE |
| K071289 | Echoview / Shimasonic Diagnostic Ultrasound System, Model SDU-1200PROITX · Traditional | 01/09/2008SE |
| K071287 | Echoview / Shimasonic Diagnostic Ultrasound Device, Model SDU-2200PROITX · Traditional | 01/09/2008SE |
| K061643 | Echo View/Shimasonic Diagnostic Ultrasound System, Model SDU-1200PROIYN · Traditional | 07/27/2006SE |
| K061637 | Echoview/ Shimasonic Diagnostic Ultrasound System, Model SDU-2200PROIYN · Traditional | 07/25/2006SE |
| K061641 | Echo View/Shimasonic Diagnostic Ultrasound System, Model SaranoIYO · Traditional | 07/14/2006SE |
| K052500 | DAR-8000FIZI · Abbreviated | 10/17/2005SE |
| K052076 | DAR-8000IIZI · Abbreviated | 09/02/2005SE |
| K050510 | Echoview/Shimasonic Diagnostic Ultrasound System, Model SDU-1100IYN · Traditional | 04/01/2005SE |
Questions and answers
When was Catheterization Table KS-60 cleared by the FDA?
Catheterization Table KS-60 (K951315) received a 510(k) decision of Substantially Equivalent on May 11, 1995, 49 days after the submission was received.
What is the product code of K951315?
The FDA product code is IZZ – Table, Radiographic, Non-Tilting, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.1980.