Catherization KS-50
FDA 510(k) K920732 · Shimadzu Medical Systems
510(k) numberK920732
Submission
- Device name
- Catherization KS-50
- Applicant
- Shimadzu Medical Systems
Gardena, CA, US - Received
- February 18, 1992
- Decision date
- April 16, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971452 | Multix Top/Pro Radiographic X-Ray TableIZZ · Traditional | Siemens Medical Solutions USA, Inc. | 05/14/1997SE |
| K952701 | Med-Tron SPECT Imaging TableIZZ · Traditional | Med-Tron Products, Inc. | 07/06/1995SE |
| K951315 | Catheterization Table KS-60IZZ · Traditional | Shimadzu Medical Systems | 05/11/1995SE |
| K951053 | Angiorex CAT-350BIZZ · Traditional | Toshiba America Medical Systems, In.C | 04/06/1995SE |
| K943926 | Rapido 2000 Automatic Radiographic TableIZZ · Traditional | Philips Medical Systems (Cleveland), Inc. | 11/28/1994SE |
| K930273 | AlphaIZZ · Traditional | Raymax Medical Corp. | 07/13/1993SE |
| K924444 | B-4 Four-Way Radiographic TableIZZ · Traditional | Control-X, Inc. | 02/05/1993SE |
| K925174 | Shimadzu Radiographic Table BK-100IZZ · Traditional | Shimadzu Medical Systems | 11/27/1992SE |
| K921501 | Deluxe C Arm Radiological Table, Model #056-004IZZ · Traditional | Biodan Medical Systems, Ltd. | 05/15/1992SE |
| K915413 | CAT-250BIZZ · Traditional | Toshiba America Medical Systems, In.C | 12/19/1991SE |
More from Toshiba America Medical Systems, In.C
| 510(k) | Device | Decision |
|---|---|---|
| K082224 | Diagnostic Ultrasound System Sarano, Echo View, ShimasonicITX · Traditional | 12/15/2008SE |
| 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 Catherization KS-50 cleared by the FDA?
Catherization KS-50 (K920732) received a 510(k) decision of Substantially Equivalent on April 16, 1992, 58 days after the submission was received.
What is the product code of K920732?
The FDA product code is IZZ – Table, Radiographic, Non-Tilting, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.1980.