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FDA 510(k)

KONICA DIRECT DIGITIZER KD-1000

K-Number: K920558 · 1992-03-06

ApplicantKonica Corp.
Decision Date1992-03-06
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KONICA DIRECT DIGITIZER KD-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Konica Corp.. It received FDA 510(k) clearance on 1992-03-06 under 510(k) number K920558. 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 KONICA DIRECT DIGITIZER KD-1000?

KONICA DIRECT DIGITIZER KD-1000 is a medical device that received FDA 510(k) clearance on 1992-03-06. The listed applicant is Konica Corp.. The 510(k) number is K920558.

When did KONICA DIRECT DIGITIZER KD-1000 receive FDA 510(k) clearance?

KONICA DIRECT DIGITIZER KD-1000 received FDA 510(k) clearance on 1992-03-06, under 510(k) number K920558.

Who is the listed applicant for KONICA DIRECT DIGITIZER KD-1000?

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

What is the FDA product code for KONICA DIRECT DIGITIZER KD-1000?

The FDA product code for KONICA DIRECT DIGITIZER KD-1000 is KPR.

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Other records listing Konica 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.

K992586KONICA LASER IMAGER, DRYPRO MODEL 722K990359KONICA DIRECT DIGITIZER, MODEL DD-341K980873KONICA DIRECT DIGITIZER REGIUS MODEL 330K920769KONICA LI 10 AND 10A LASER IMAGER

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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