Panatome

FDA 510(k) K991518 · Imaging Sciences Intl., Inc.

Substantially Equivalent

510(k) numberK991518

Submission

Device name
Panatome
Applicant
Imaging Sciences Intl., Inc.
Hatfield, PA, US
Received
April 30, 1999
Decision date
June 18, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EHD – Unit, X-Ray, Extraoral With Timer
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Specialty
Dental

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K252110Dental X-RAY Unit (AJX200)EHD · Traditional Guangzhou Ajax Medical Equipment Co., Ltd.03/12/2026SE
K254018Portable Dental X-ray Device (GT-1)EHD · Traditional Guilin Refine Medical Instrument Co., Ltd.02/19/2026SE
K252909Diagnostic X-Ray Equipment Model POCT22EHD · Traditional Ningbo Runyes Medical Instrument Co., Ltd.02/03/2026SE
K251438Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )EHD · Special Guilin Woodpecker Medical Instrument Co., Ltd.09/04/2025SE
K242185Rextar ProEHD · Traditional Raypia Co., Ltd.12/04/2024SE
K242591XERO-alphaEHD · Traditional DRTECH Corporation11/01/2024SE
K241963WerayEHD · Traditional Picopack Co., Ltd.07/30/2024SE
K241305LifeRay Intraoral Handheld X-ray SystemEHD · Traditional Lucas Lifecare07/05/2024SE

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K001248Multi-Pulse 2000EHD · Traditional 05/04/2000SE
K981466XR-910IZL · Traditional 07/14/1998SE
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Questions and answers

When was Panatome cleared by the FDA?

Panatome (K991518) received a 510(k) decision of Substantially Equivalent on June 18, 1999, 49 days after the submission was received.

What is the product code of K991518?

The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.