Collimator, Heart Contour
FDA 510(k) K781984 · Siemens Corp.
510(k) numberK781984
Submission
- Device name
- Collimator, Heart Contour
- Applicant
- Siemens Corp.
Mchenry, IL, US - Received
- November 24, 1978
- Decision date
- December 4, 1978
- 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 |
|---|---|---|
| K150843 | syngo®.via (version VB10A)LLZ · Abbreviated | 04/24/2015SE |
| K123375 | Syngo.ViaLLZ · Traditional | 11/20/2012SE |
| K110366 | Syngo.Ct Cardiac FunctionJAK · Traditional | 04/12/2011SE |
| K103360 | Dimension Vista Digitoxin Calibrator - DGTX CalJIT · Traditional | 12/17/2010SE |
| K081182 | Microscan Dried Gram-Positive Mic/Combo Panels New Antimicrobial Test - Inducible…JWY · Traditional | 08/08/2008SE |
| K071310 | Syngo CT Oncology Software PackageJAK · Traditional | 06/08/2007SE |
| K063507 | Syngo Neuro PBV CTJAK · Traditional | 11/30/2006SE |
| K063373 | Flex Loop Coil Set 3TMOS · Traditional | 11/17/2006SE |
| K053024 | Syngo Neuro Dsa CTJAK · Traditional | 11/04/2005SE |
| K050867 | Syngo Body Perfusion-CtJAK · Traditional | 04/14/2005SE |
Questions and answers
When was Collimator, Heart Contour cleared by the FDA?
Collimator, Heart Contour (K781984) received a 510(k) decision of Substantially Equivalent on December 4, 1978, 10 days after the submission was received.
What is the product code of K781984?
The FDA product code is KPW – Device, Beam Limiting, X-Ray, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1610.