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FDA 510(k)

ADC COMPACT (AGFA DIAGNOSTIC CENTER)

K-Number: K974597 · 1998-03-09

ApplicantBayer Corp., Agfa Div.
Decision Date1998-03-09
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADC COMPACT (AGFA DIAGNOSTIC CENTER) is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp., Agfa Div.. It received FDA 510(k) clearance on 1998-03-09 under 510(k) number K974597. 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 ADC COMPACT (AGFA DIAGNOSTIC CENTER)?

ADC COMPACT (AGFA DIAGNOSTIC CENTER) is a medical device that received FDA 510(k) clearance on 1998-03-09. The listed applicant is Bayer Corp., Agfa Div.. The 510(k) number is K974597.

When did ADC COMPACT (AGFA DIAGNOSTIC CENTER) receive FDA 510(k) clearance?

ADC COMPACT (AGFA DIAGNOSTIC CENTER) received FDA 510(k) clearance on 1998-03-09, under 510(k) number K974597.

Who is the listed applicant for ADC COMPACT (AGFA DIAGNOSTIC CENTER)?

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

What is the FDA product code for ADC COMPACT (AGFA DIAGNOSTIC CENTER)?

The FDA product code for ADC COMPACT (AGFA DIAGNOSTIC CENTER) is KPR.

Related Clinical Trials

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.

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Other records listing Bayer Corp., Agfa Div. 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.

K981280CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMSK964414LR 5200 LASER FILM RECORDER

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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