Collimator, Automatic
FDA 510(k) K770335 · Litton Medical Systems
510(k) numberK770335
Submission
- Device name
- Collimator, Automatic
- Applicant
- Litton Medical Systems
Mchenry, IL, US - Received
- February 18, 1977
- Decision date
- February 28, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KPW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093596 | Lumos, Model R 72BKPW · Traditional | Lumos, Inc. | 01/12/2010SE |
| K062788 | Collimator, Model M-38KPW · Traditional | Umi International | 12/28/2006SE |
| K030487 | R 72KPW · Traditional | Ralco S.R.L. | 08/01/2003SE |
| K954310 | BLA-800AKPW · Traditional | Toshiba Medical Systems | 10/18/1995SE |
| K946320 | R 302KPW · Traditional | Ralco S.R.L. | 05/11/1995SE |
| K914184 | P2020-8-0 Beam-Limiting DeviceKPW · Traditional | Precise Optics | 11/27/1991SE |
| K904587 | Densicomp 250KPW · Traditional | L. Keroack Co. | 01/24/1991SE |
| K904044 | TF-63SAKPW · Traditional | Toshiba America Medical Systems, In.C | 11/29/1990SE |
| K904489 | Eureka Extension CylindersKPW · Traditional | Eureka X-Ray Tube Corp. | 10/15/1990SE |
| K820306 | Ralco Collimator, Automatic RadiographicKPW · Traditional | Tecnomed, Inc. | 03/05/1982SE |
More from Tecnomed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K770338 | X-Ray Control & X-Ray HV GeneratorIZO · Traditional | 03/01/1977SE |
| K770337 | Fluoroscopic Assembly, Image Intens.JAA · Traditional | 03/01/1977SE |
| K770336 | X-Ray Tube, Rotating AnodeITY · Traditional | 03/01/1977SE |
| K770334 | Tilting X-Ray TableIXR · Traditional | 03/01/1977SE |
| K770333 | Fluoroscope, C-ArmJAA · Traditional | 03/01/1977SE |
| K760569 | Three Phase X-Ray Controls & HV GeneratorsIZO · Traditional | 09/15/1976SE |
| K760568 | Single Phase X-Ray Controls & HV GeneratorsIZO · Traditional | 09/15/1976SE |
Questions and answers
When was Collimator, Automatic cleared by the FDA?
Collimator, Automatic (K770335) received a 510(k) decision of Substantially Equivalent on February 28, 1977, 10 days after the submission was received.
What is the product code of K770335?
The FDA product code is KPW – Device, Beam Limiting, X-Ray, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1610.