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FDA 510(k)

ORTHOPHOS 3/ ORTHOPHOS 3C

K-Number: K936068 · 1994-07-29

ApplicantPelton & Crane Co.
Decision Date1994-07-29
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOPHOS 3/ ORTHOPHOS 3C is the device name listed in this FDA 510(k) record. The listed applicant is Pelton & Crane Co.. It received FDA 510(k) clearance on 1994-07-29 under 510(k) number K936068. The device is classified under product code EAP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOPHOS 3/ ORTHOPHOS 3C?

ORTHOPHOS 3/ ORTHOPHOS 3C is a medical device that received FDA 510(k) clearance on 1994-07-29. The listed applicant is Pelton & Crane Co.. The 510(k) number is K936068.

When did ORTHOPHOS 3/ ORTHOPHOS 3C receive FDA 510(k) clearance?

ORTHOPHOS 3/ ORTHOPHOS 3C received FDA 510(k) clearance on 1994-07-29, under 510(k) number K936068.

Who is the listed applicant for ORTHOPHOS 3/ ORTHOPHOS 3C?

The FDA 510(k) record lists Pelton & Crane Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHOPHOS 3/ ORTHOPHOS 3C?

The FDA product code for ORTHOPHOS 3/ ORTHOPHOS 3C is EAP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pelton & Crane Co. 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.

K972249ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CDK972168SIDEXIS DIGITAL RADIOGRAPHY SYSTEMK945117DELTAK962071SPIRIT S1/S2K960819HELIODENT DSK950299CEREC 2

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Related Devices (Code: EAP)

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.

K113360MEDICAL IMAGE PROCESSING UNITHumanray Co,LtdK102573PROVU (TM) DENTAL X-RAY SYSTEMAdvanced Image Science, Inc.K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.K080738DENTRON SENSORDentron Systems, LLCK052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)Flow X-Ray Corp.K041385MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.

Official Source

View on FDA Database →

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

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