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FDA 510(k)

DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST

K-Number: K070678 · 2007-05-02

ApplicantSwissray International, Inc.
Decision Date2007-05-02
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST is the device name listed in this FDA 510(k) record. The listed applicant is Swissray International, Inc.. It received FDA 510(k) clearance on 2007-05-02 under 510(k) number K070678. 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 DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST?

DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST is a medical device that received FDA 510(k) clearance on 2007-05-02. The listed applicant is Swissray International, Inc.. The 510(k) number is K070678.

When did DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST receive FDA 510(k) clearance?

DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST received FDA 510(k) clearance on 2007-05-02, under 510(k) number K070678.

Who is the listed applicant for DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST?

The FDA 510(k) record lists Swissray International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST?

The FDA product code for DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST is KPR.

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Other records listing Swissray International, Inc. 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.

K050718DDRCOMBI TRAUMAK973710DIGITAL ADD ON MULTI SYSTEM

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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