X-Ray Tube, Rotating Anode
FDA 510(k) K770336 · Litton Medical Systems
510(k) numberK770336
Submission
- Device name
- X-Ray Tube, Rotating Anode
- Applicant
- Litton Medical Systems
Mchenry, IL, US - Received
- February 18, 1977
- Decision date
- March 1, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code ITY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000052 | X-Ray Monoblock, Monoblock XRS-60-330ITY · Traditional | Dynarad Corp. | 02/10/2000SE |
| K933162 | MRX-750ITY · Traditional | Mrx Corp. | 10/07/1993SE |
| K923094 | MolybdenumITY · Traditional | Southeastern Medical Diagnostics, Inc. | 03/04/1993SE |
| K923141 | Philips Pre-Filter OptionITY · Traditional | Philips Medical Systems, Inc. | 01/21/1993SE |
| K921129 | MRX-700ITY · Traditional | Mrx-Ray Tube Corp. | 10/05/1992SE |
| K921130 | MRX-865ITY · Traditional | Mrx-Ray Tube Corp. | 09/10/1992SE |
| K921316 | MG-1001 Tube Housing AssemblyITY · Traditional | Magma Corp. | 06/22/1992SE |
| K920731 | X-Ray Tube Assembly CIRCLEX1.2UGITY · Traditional | Shimadzu Medical Systems | 05/29/1992SE |
| K920724 | High Speed Rotation Starter SA-50ITY · Traditional | Shimadzu Medical Systems | 04/27/1992SE |
| K920723 | High Speed Rotation Starter SA-40ITY · Traditional | Shimadzu Medical Systems | 04/27/1992SE |
More from Shimadzu Medical Systems
| 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 |
| K770334 | Tilting X-Ray TableIXR · Traditional | 03/01/1977SE |
| K770333 | Fluoroscope, C-ArmJAA · Traditional | 03/01/1977SE |
| K770335 | Collimator, AutomaticKPW · Traditional | 02/28/1977SE |
| 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 X-Ray Tube, Rotating Anode cleared by the FDA?
X-Ray Tube, Rotating Anode (K770336) received a 510(k) decision of Substantially Equivalent on March 1, 1977, 11 days after the submission was received.
What is the product code of K770336?
The FDA product code is ITY – Assembly, Tube Housing, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1760.