X-Ray Tube Assembly CIRCLEX1.2UG
FDA 510(k) K920731 · Shimadzu Medical Systems
510(k) numberK920731
Submission
- Device name
- X-Ray Tube Assembly CIRCLEX1.2UG
- Applicant
- Shimadzu Medical Systems
Gardena, CA, US - Received
- February 18, 1992
- Decision date
- May 29, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K921129 | MRX-700ITY · Traditional | Mrx-Ray Tube Corp. | 10/05/1992SE |
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| K921316 | MG-1001 Tube Housing AssemblyITY · Traditional | Magma Corp. | 06/22/1992SE |
| K920724 | High Speed Rotation Starter SA-50ITY · Traditional | Shimadzu Medical Systems | 04/27/1992SE |
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| 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 |
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Questions and answers
When was X-Ray Tube Assembly CIRCLEX1.2UG cleared by the FDA?
X-Ray Tube Assembly CIRCLEX1.2UG (K920731) received a 510(k) decision of Substantially Equivalent on May 29, 1992, 101 days after the submission was received.
What is the product code of K920731?
The FDA product code is ITY – Assembly, Tube Housing, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1760.