Transworld 360V, Model A1-4040
FDA 510(k) K872357 · Transworld X-Ray Corp.
510(k) numberK872357
Submission
- Device name
- Transworld 360V, Model A1-4040
- Applicant
- Transworld X-Ray Corp.
Charlotte, NC, US - Received
- June 18, 1987
- Decision date
- July 15, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954666 | MPH50, MPH65, and MPH80IZO · Traditional | GE Medical Systems | 11/24/1995SE |
| K953582 | HFX350, 30KW, 300MA, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray GeneratorIZO · Traditional | Varian Canada, Inc. | 09/26/1995SE |
| K953831 | N 800 HFIZO · Traditional | Nucletron-Oldelft Corp. | 09/08/1995SE |
| K952822 | Shimadzu X-Ray High Viltage Generator AHD150GIZO · Traditional | Shimadzu Corp. | 07/12/1995SE |
| K952265 | Milestonw 350/450/550HF, PCX N350/450/550HF, Top-X 350/450/550HF Radiographic X-Ray…IZO · Traditional | Control-X, Inc. | 07/06/1995SE |
| K950883 | Polydoros SX 65 and 80IZO · Traditional | Siemens Medical Solutions USA, Inc. | 04/03/1995SE |
| K950694 | Compact-XIZO · Traditional | Electromed Intl., Ltd. | 03/31/1995SE |
| K950291 | Digital 625HFIZO · Traditional | Fischer Imaging Corp. | 03/23/1995SE |
| K950041 | Sii 360 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
| K950040 | Sii 525 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
More from Scott Imaging Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K892657 | SensimatIZO · Traditional | 06/23/1989SE |
| K890066 | Star 36IZO · Traditional | 03/28/1989SE |
| K873283 | Model C2-5000 Overhead Tube SupportIYB · Traditional | 09/10/1987SE |
| K872980 | Mam-Cp X-Ray ApparatusIZH · Traditional | 08/27/1987SE |
| K841923 | DCX-100 Chest UNIT-GL-5000MKPR · Traditional | 08/10/1984SE |
| K827582 | Modified X-Ray Table · Traditional | 07/09/1982SE |
Questions and answers
When was Transworld 360V, Model A1-4040 cleared by the FDA?
Transworld 360V, Model A1-4040 (K872357) received a 510(k) decision of Substantially Equivalent on July 15, 1987, 27 days after the submission was received.
What is the product code of K872357?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.