Ralco Collimators, Manual Radiographic
FDA 510(k) K820305 · Tecnomed, Inc.
510(k) numberK820305
Submission
- Device name
- Ralco Collimators, Manual Radiographic
- Applicant
- Tecnomed, Inc.
Mchenry, IL, US - Received
- February 4, 1982
- Decision date
- March 4, 1982
- 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 |
|---|---|---|
| K892226 | Tec 6340 90/15 Radiographic/Fluoroscopic TableIXR · Traditional | 04/26/1989SE |
| K854203 | Tec 2720 Mamex DC MagIZH · Traditional | 03/06/1986SE |
| K827126 | Technomed Generator, Radiographic, 3 Phase · Traditional | 03/05/1982SE |
| K827124 | Ralco Collimator, Automatic, Radiographic · Traditional | 03/05/1982SE |
| K820307 | Tecnomed Generator, Radiograph., 3 PhaseIZO · Traditional | 03/05/1982SE |
| K820306 | Ralco Collimator, Automatic RadiographicKPW · Traditional | 03/05/1982SE |
| K827125 | Ralco Collimators, Manual, Radiographic · Traditional | 03/04/1982SE |
| K811197 | Superix 120IZF · Traditional | 06/09/1981SE |
| K811196 | Allmec 90/15KXJ · Traditional | 06/09/1981SE |
| K811195 | ArgostatIYB · Traditional | 06/09/1981SE |
Questions and answers
When was Ralco Collimators, Manual Radiographic cleared by the FDA?
Ralco Collimators, Manual Radiographic (K820305) received a 510(k) decision of Substantially Equivalent on March 4, 1982, 28 days after the submission was received.
What is the product code of K820305?
The FDA product code is KPW – Device, Beam Limiting, X-Ray, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1610.