High Speed Rotation Starter SA-40
FDA 510(k) K920723 · Shimadzu Medical Systems
510(k) numberK920723
Submission
- Device name
- High Speed Rotation Starter SA-40
- Applicant
- Shimadzu Medical Systems
Gardena, CA, US - Received
- February 18, 1992
- Decision date
- April 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code ITY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000052 | X-Ray Monoblock, Monoblock XRS-60-330ITY · Traditional | Dynarad Corp. | 02/10/2000SE |
| K933162 | MRX-750ITY · Traditional | Mrx Corp. | 10/07/1993SE |
| K923094 | MolybdenumITY · Traditional | Southeastern Medical Diagnostics, Inc. | 03/04/1993SE |
| K923141 | Philips Pre-Filter OptionITY · Traditional | Philips Medical Systems, Inc. | 01/21/1993SE |
| K921129 | MRX-700ITY · Traditional | Mrx-Ray Tube Corp. | 10/05/1992SE |
| K921130 | MRX-865ITY · Traditional | Mrx-Ray Tube Corp. | 09/10/1992SE |
| K921316 | MG-1001 Tube Housing AssemblyITY · Traditional | Magma Corp. | 06/22/1992SE |
| K920731 | X-Ray Tube Assembly CIRCLEX1.2UGITY · Traditional | Shimadzu Medical Systems | 05/29/1992SE |
| K920724 | High Speed Rotation Starter SA-50ITY · Traditional | Shimadzu Medical Systems | 04/27/1992SE |
| K920387 | CIRCLEXO.3T X-Ray Tube AssemblyITY · Traditional | Shimadzu Medical Systems | 04/14/1992SE |
More from Shimadzu Medical Systems
| 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 High Speed Rotation Starter SA-40 cleared by the FDA?
High Speed Rotation Starter SA-40 (K920723) received a 510(k) decision of Substantially Equivalent on April 27, 1992, 69 days after the submission was received.
What is the product code of K920723?
The FDA product code is ITY – Assembly, Tube Housing, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1760.