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FDA 510(k)

DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM

K-Number: K001336 · 2000-06-02

ApplicantAnalogic Corp.
Decision Date2000-06-02
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Analogic Corp.. It received FDA 510(k) clearance on 2000-06-02 under 510(k) number K001336. 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 DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM?

DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2000-06-02. The listed applicant is Analogic Corp.. The 510(k) number is K001336.

When did DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM receive FDA 510(k) clearance?

DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM received FDA 510(k) clearance on 2000-06-02, under 510(k) number K001336.

Who is the listed applicant for DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM?

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

What is the FDA product code for DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM?

The FDA product code for DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM is KPR.

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Other records listing Analogic 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.

K071430SYNERAD OMNI, MODELS AN6255 AND AN6265K052447SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600K050919LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423PK043025SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250K041434C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORSK041376C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A

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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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