Shimadzu Image Amplifier IA-9LM Series
FDA 510(k) K923453 · Shimadzu Medical Systems
510(k) numberK923453
Submission
- Device name
- Shimadzu Image Amplifier IA-9LM Series
- Applicant
- Shimadzu Medical Systems
Gardena, CA, US - Received
- July 14, 1992
- Decision date
- October 5, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 Shimadzu Image Amplifier IA-9LM Series cleared by the FDA?
Shimadzu Image Amplifier IA-9LM Series (K923453) received a 510(k) decision of Substantially Equivalent on October 5, 1992, 83 days after the submission was received.
What is the product code of K923453?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.