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FDA 510(k)

APOLLO

K-Number: K050190 · 2005-03-25

ApplicantVilla Sistemi Medicali S.P.A.
Decision Date2005-03-25
Product CodeKXJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

APOLLO is the device name listed in this FDA 510(k) record. The listed applicant is Villa Sistemi Medicali S.P.A.. It received FDA 510(k) clearance on 2005-03-25 under 510(k) number K050190. The device is classified under product code KXJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APOLLO?

APOLLO is a medical device that received FDA 510(k) clearance on 2005-03-25. The listed applicant is Villa Sistemi Medicali S.P.A.. The 510(k) number is K050190.

When did APOLLO receive FDA 510(k) clearance?

APOLLO received FDA 510(k) clearance on 2005-03-25, under 510(k) number K050190.

Who is the listed applicant for APOLLO?

The FDA 510(k) record lists Villa Sistemi Medicali S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APOLLO?

The FDA product code for APOLLO is KXJ.

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Other records listing Villa Sistemi Medicali S.P.A. 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.

K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)K162190Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)K130109ENDOGRAPH DCK111152ROTOGRAPH EVO 3DK090749ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191K080859DRF 4343

View all 13 devices →

Related Devices (Code: KXJ)

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.

K963905RADIOGRAPHIC ITT TABLEX-Ray Technologies, Inc.K955414XRT 400Wuestec Medical, Inc.K951146IMAGING TABLESepta Corp.K950068CARBON FIBER COUCH INSERTMedtec, Inc.K950442INFRARED EXPOSURE HAND SWITCHMedical X-Ray Intl., Inc.K940696SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5Philips Medical Systems North America, 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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