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FDA 510(k)

DIGITAL RADIOGRAPHY CHEST DEVICE

K-Number: K803049 · 1981-03-02

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1981-03-02
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL RADIOGRAPHY CHEST DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1981-03-02 under 510(k) number K803049. 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 DIGITAL RADIOGRAPHY CHEST DEVICE?

DIGITAL RADIOGRAPHY CHEST DEVICE is a medical device that received FDA 510(k) clearance on 1981-03-02. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K803049.

When did DIGITAL RADIOGRAPHY CHEST DEVICE receive FDA 510(k) clearance?

DIGITAL RADIOGRAPHY CHEST DEVICE received FDA 510(k) clearance on 1981-03-02, under 510(k) number K803049.

Who is the listed applicant for DIGITAL RADIOGRAPHY CHEST DEVICE?

The FDA 510(k) record lists Philips Medical Systems (Cleveland), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL RADIOGRAPHY CHEST DEVICE?

The FDA product code for DIGITAL RADIOGRAPHY CHEST DEVICE is KPR.

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Other records listing Philips Medical Systems (Cleveland), Inc. as applicant

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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

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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