Panoramic Corporation HDLX

Q: What is the product code of K943532?

The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.

FDA 510(k) K943532 · Panoramic Corp.

Substantially Equivalent

510(k) numberK943532

Submission

Device name: Panoramic Corporation HDLX
Applicant: Panoramic Corp.
Ft. Wayne, IN, US
Received: July 21, 1994
Decision date: December 7, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JAA – System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1650
Specialty: Radiology

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Questions and answers

When was Panoramic Corporation HDLX cleared by the FDA?

Panoramic Corporation HDLX (K943532) received a 510(k) decision of Substantially Equivalent on December 7, 1994, 139 days after the submission was received.

What is the product code of K943532?

The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.