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FDA 510(k)

ORCA

K-Number: K960907 · 1996-05-20

ApplicantLunar Corp.
Decision Date1996-05-20
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORCA is the device name listed in this FDA 510(k) record. The listed applicant is Lunar Corp.. It received FDA 510(k) clearance on 1996-05-20 under 510(k) number K960907. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORCA?

ORCA is a medical device that received FDA 510(k) clearance on 1996-05-20. The listed applicant is Lunar Corp.. The 510(k) number is K960907.

When did ORCA receive FDA 510(k) clearance?

ORCA received FDA 510(k) clearance on 1996-05-20, under 510(k) number K960907.

Who is the listed applicant for ORCA?

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

What is the FDA product code for ORCA?

The FDA product code for ORCA is OXO.

Other records listing Lunar Corp. 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.

K001812PEDIATRIC REFERENCE DATAK001756LUNAR REPORT GENERATOR IIK000826PRODIGY LATERAL VIEW SOFTWAREK983564PRODIGY TOTAL BODY SOFTWAREK983724ORCA-DX BONE DENSITOMETERK983271FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS

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Related Devices (Code: OXO)

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.

K253296Digital C-ARM with 3DAllengers Medical Systems LimitedK252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd.K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, 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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