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FDA 510(k)

CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM

K-Number: K081836 · 2008-07-30

ApplicantCarestream Health, Inc.
Decision Date2008-07-30
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2008-07-30 under 510(k) number K081836. 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 CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM?

CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-30. The listed applicant is Carestream Health, Inc.. The 510(k) number is K081836.

When did CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM receive FDA 510(k) clearance?

CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM received FDA 510(k) clearance on 2008-07-30, under 510(k) number K081836.

Who is the listed applicant for CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM?

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

What is the FDA product code for CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM?

The FDA product code for CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM is KPR.

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Other records listing Carestream Health, 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.

K251168Image SuiteK241505DRX-Revolution Mobile X-ray SystemK233381DRX-Evolution Plus SystemK223842DRX - CompassK213307Eclipse II with Smart Noise CancellationK202441Eclipse II with Smart Noise Cancellation

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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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