Cine Camera Control Model PK2037
FDA 510(k) K896615 · Perkins Mfg. Co.
510(k) numberK896615
Submission
- Device name
- Cine Camera Control Model PK2037
- Applicant
- Perkins Mfg. Co.
Dallas, TX, US - Received
- November 21, 1989
- Decision date
- January 4, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IZJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K024085 | CCD Camera, Model PKP-06000-000IZJ · Traditional | Perkins Electronics Co. | 03/11/2003SE |
| K972130 | Disposable Camera Cover, Enclosed: Disposable Camera Cover, Perforated: Disposable…IZJ · Traditional | Fairmontmedical | 10/09/1997SE |
| K945580 | DSP OptionIZJ · Traditional | Philips Medical Systems (Cleveland), Inc. | 01/30/1995SE |
| K920793 | Philips Dsi System Release 3.2IZJ · Traditional | Philips Medical Systems, Inc. | 07/17/1992SE |
| K881688 | DTV-4114 Fluoroscopic Television CameraIZJ · Traditional | Adac Laboratories | 05/18/1988SE |
| K853983 | Canon X-Ray 35MM Cine Camera CSI-35IZJ · Traditional | Canon USA, Inc. | 10/16/1985SE |
| K812613 | Vidicam 200IZJ · Traditional | Diversified P.A. | 12/08/1981SE |
| K810191 | Sircam 103IZJ · Traditional | Siemens Corp. | 02/26/1981SE |
| K810072 | 105MM Roll Film Fluorogr. Camera, #105IZJ · Traditional | Scientex Corp. | 02/12/1981SE |
| K802132 | 105MM Spot Film CameraIZJ · Traditional | Instrumentation Camera, Inc. | 10/23/1980SE |
More from Instrumentation Camera, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972136 | TV Monitor (P12/17)IZI · Traditional | 06/26/1997SE |
| K954222 | Video Enhancement UnitLLZ · Traditional | 12/08/1995SE |
| K926348 | SC1000 Scan ConverterLMB · Traditional | 11/19/1993SE |
| K920550 | Display Processor - Model IDP5100JAA · Traditional | 04/13/1992SE |
| K915232 | Grundig Electronics Various ModelsIZI · Traditional | 01/09/1992SE |
| K910384 | Video Annotator Model PK2310JAA · Traditional | 04/16/1991SE |
| K904986 | Programmable Video Controller Model PK2060JAA · Traditional | 12/04/1990SE |
| K904540 | Video System Interface ModelsIZI · Traditional | 10/26/1990SE |
| K895500 | Patient Positioning AccessoriesIYE · Traditional | 11/06/1989SE |
| K893644 | PK2025/PK2045 Programmable Video ControllerJAA · Traditional | 08/09/1989SE |
Questions and answers
When was Cine Camera Control Model PK2037 cleared by the FDA?
Cine Camera Control Model PK2037 (K896615) received a 510(k) decision of Substantially Equivalent on January 4, 1990, 44 days after the submission was received.
What is the product code of K896615?
The FDA product code is IZJ – Camera, X-Ray, Fluorographic, Cine Or Spot, a Class II (moderate risk) device regulated under 21 CFR 892.1620.