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FDA 510(k)

ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY

K-Number: K880982 · 1988-06-06

ApplicantOrion Corporation Soredex
Decision Date1988-06-06
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY is the device name listed in this FDA 510(k) record. The listed applicant is Orion Corporation Soredex. It received FDA 510(k) clearance on 1988-06-06 under 510(k) number K880982. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY?

ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY is a medical device that received FDA 510(k) clearance on 1988-06-06. The listed applicant is Orion Corporation Soredex. The 510(k) number is K880982.

When did ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY receive FDA 510(k) clearance?

ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY received FDA 510(k) clearance on 1988-06-06, under 510(k) number K880982.

Who is the listed applicant for ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY?

The FDA 510(k) record lists Orion Corporation Soredex as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY?

The FDA product code for ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY is KPR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Orion Corporation Soredex as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983267DIGORA FOR WINDOWS 2.0K974877CRANEX TOME CEPH, OR CRANEX TOMEK934949DIGORA

Related Devices (Code: KPR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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