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FDA 510(k)

HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST

K-Number: K913757 · 1991-10-30

ApplicantHologic, Inc.
Decision Date1991-10-30
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 1991-10-30 under 510(k) number K913757. 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 HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST?

HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST is a medical device that received FDA 510(k) clearance on 1991-10-30. The listed applicant is Hologic, Inc.. The 510(k) number is K913757.

When did HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST receive FDA 510(k) clearance?

HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST received FDA 510(k) clearance on 1991-10-30, under 510(k) number K913757.

Who is the listed applicant for HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST?

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

What is the FDA product code for HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST?

The FDA product code for HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST is KPR.

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Other records listing Hologic, 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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