Dental Radiographic 90, Model PM 2002 CC Panoramic
FDA 510(k) K864474 · Planmeca USA, Inc.
510(k) numberK864474
Submission
- Device name
- Dental Radiographic 90, Model PM 2002 CC Panoramic
- Applicant
- Planmeca USA, Inc.
Richmond, VA, US - Received
- November 13, 1986
- Decision date
- November 26, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| K260367 | Portable Dental X-ray System Model PDX novaEHD · Traditional | PDX Co., Ltd. | 05/27/2026SE |
| K253864 | NOMAD Pro 3EHD · Traditional | Dental Imaging Technologies Corporation | 03/20/2026SE |
| K252110 | Dental X-RAY Unit (AJX200)EHD · Traditional | Guangzhou Ajax Medical Equipment Co., Ltd. | 03/12/2026SE |
| K254018 | Portable Dental X-ray Device (GT-1)EHD · Traditional | Guilin Refine Medical Instrument Co., Ltd. | 02/19/2026SE |
| K252909 | Diagnostic X-Ray Equipment Model POCT22EHD · Traditional | Ningbo Runyes Medical Instrument Co., Ltd. | 02/03/2026SE |
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )EHD · Special | Guilin Woodpecker Medical Instrument Co., Ltd. | 09/04/2025SE |
| K242185 | Rextar ProEHD · Traditional | Raypia Co., Ltd. | 12/04/2024SE |
| K242591 | XERO-alphaEHD · Traditional | DRTECH Corporation | 11/01/2024SE |
| K241963 | WerayEHD · Traditional | Picopack Co., Ltd. | 07/30/2024SE |
| K241305 | LifeRay Intraoral Handheld X-ray SystemEHD · Traditional | Lucas Lifecare | 07/05/2024SE |
More from Lucas Lifecare
| 510(k) | Device | Decision |
|---|---|---|
| K111361 | Planmed Nuance ExcelMUE · Traditional | 09/23/2011SE |
| K081699 | Planmeca SovereignEIA · Traditional | 08/29/2008SE |
| K923534 | PM2002 ProlineKLC · Traditional | 01/31/1994SE |
| K923533 | AdmarkJAC · Traditional | 03/04/1993SE |
| K923462 | DelightEAZ · Traditional | 12/21/1992SE |
| K923461 | PM2002 Proline, PM2002 Proline EcKLC · Traditional | 12/21/1992SE |
| K904953 | Planmed SophieIZH · Traditional | 04/18/1991SE |
| K904948 | PM2002 CC and PM2002 EcEIA · Traditional | 01/30/1991SE |
| K904947 | PM2002 CC, Aristocrat and Aristocrat DeluxeBZG · Traditional | 01/30/1991SE |
| K842359 | Automatic Patient Chair PM2000 & a · Traditional | 09/19/1984SE |
Questions and answers
When was Dental Radiographic 90, Model PM 2002 CC Panoramic cleared by the FDA?
Dental Radiographic 90, Model PM 2002 CC Panoramic (K864474) received a 510(k) decision of Substantially Equivalent on November 26, 1986, 13 days after the submission was received.
What is the product code of K864474?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.