ATC725, ATC525, and AP300
FDA 510(k) K922165 · Gendex Corp.
510(k) numberK922165
Submission
- Device name
- ATC725, ATC525, and AP300
- Applicant
- Gendex Corp.
Des Plaines, IL, US - Received
- May 8, 1992
- Decision date
- July 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
|---|---|---|
| K952598 | Gx-Pan Panoramic Dental X-Ray SystemGEX · Traditional | 06/29/1995SE |
| K945682 | Processor, Radiographic-Film, Automatic, DentalEGY · Traditional | 02/09/1995SE |
| K935046 | GX-770 X-Ray Control, Model 46-404600G4EHD · Traditional | 02/18/1994SE |
| K925094 | Visualix Radiographic Image Detecting and ProcessEHD · Traditional | 09/29/1993SE |
| K931001 | Oralix DCEHD · Traditional | 09/14/1993SE |
| K932675 | GXP Dental X-Ray ProcessorEGN · Traditional | 07/26/1993SE |
| K920189 | Gx-C CephalometerEAG · Traditional | 04/28/1992SE |
| K894188 | Gx-ElevatorIZZ · Traditional | 10/03/1989SE |
| K890083 | GX-2000 Stationary X-Ray GeneratorIZO · Traditional | 03/31/1989SE |
| K873982 | Gx-Mobile X-Ray UnitIZL · Traditional | 10/30/1987SE |
Questions and answers
When was ATC725, ATC525, and AP300 cleared by the FDA?
ATC725, ATC525, and AP300 (K922165) received a 510(k) decision of Substantially Equivalent on July 27, 1992, 80 days after the submission was received.
What is the product code of K922165?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.