Hi-Sensitivity Mode Option for S60-1A
FDA 510(k) K761332 · Syntex Corp.
510(k) numberK761332
Submission
- Device name
- Hi-Sensitivity Mode Option for S60-1A
- Applicant
- Syntex Corp.
Mchenry, IL, US - Received
- December 27, 1976
- Decision date
- December 30, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
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| K920314 | Txit D.A.U. Barbiturate Assay (Modification)DIS · Traditional | 04/17/1992SE |
| K843593 | Surgipress Surgical LoopHRQ · Traditional | 10/24/1984SE |
| K780997 | Amalgam AlloyEJJ · Traditional | 07/27/1978SE |
| K780769 | S-100 CT ScannerJAK · Traditional | 06/02/1978SE |
| K780483 | Fiber Optic HandpieceEFB · Traditional | 04/28/1978SE |
| K761331 | Opus I Option - Fiber Optic L SystemEAY · Traditional | 01/03/1977SE |
| K761330 | Syntex System 6000JAK · Traditional | 12/30/1976SE |
| K761264 | Options for Star Dental Opus IDYN · Traditional | 12/23/1976SE |
| K761033 | Computerized Tomography ScannerJAK · Traditional | 11/24/1976SE |
Questions and answers
When was Hi-Sensitivity Mode Option for S60-1A cleared by the FDA?
Hi-Sensitivity Mode Option for S60-1A (K761332) received a 510(k) decision of Substantially Equivalent on December 30, 1976, 3 days after the submission was received.
What is the product code of K761332?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.