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FDA 510(k)

UPSCAN

K-Number: K933512 · 1995-04-19

ApplicantMerlin Engineering Works, Inc.
Decision Date1995-04-19
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UPSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Merlin Engineering Works, Inc.. It received FDA 510(k) clearance on 1995-04-19 under 510(k) number K933512. 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 UPSCAN?

UPSCAN is a medical device that received FDA 510(k) clearance on 1995-04-19. The listed applicant is Merlin Engineering Works, Inc.. The 510(k) number is K933512.

When did UPSCAN receive FDA 510(k) clearance?

UPSCAN received FDA 510(k) clearance on 1995-04-19, under 510(k) number K933512.

Who is the listed applicant for UPSCAN?

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

What is the FDA product code for UPSCAN?

The FDA product code for UPSCAN is KPR.

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Other records listing Merlin Engineering Works, 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.

K974882DOWNSCAN LTK971154MULTIPICS(ME-977)K971153SPLITSCREEN (ME-975)K970451DOWNSCAN 120K970450UPSCAN 120K954211CRISPICS

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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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