Ceiling Suspended C-Arm Support MH-100
FDA 510(k) K943545 · Shimadzu Medical Systems
510(k) numberK943545
Submission
- Device name
- Ceiling Suspended C-Arm Support MH-100
- Applicant
- Shimadzu Medical Systems
Torrance, CA, US - Received
- July 21, 1994
- Decision date
- February 3, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K082224 | Diagnostic Ultrasound System Sarano, Echo View, ShimasonicITX · Traditional | 12/15/2008SE |
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| 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 Ceiling Suspended C-Arm Support MH-100 cleared by the FDA?
Ceiling Suspended C-Arm Support MH-100 (K943545) received a 510(k) decision of Substantially Equivalent on February 3, 1995, 197 days after the submission was received.
What is the product code of K943545?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.