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FDA 510(k)

X-CELL X-RAY #'S P-75W/P-75M

K-Number: K811230 · 1981-06-23

ApplicantX-Cel X-Ray Corp.
Decision Date1981-06-23
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-CELL X-RAY #'S P-75W/P-75M is the device name listed in this FDA 510(k) record. The listed applicant is X-Cel X-Ray Corp.. It received FDA 510(k) clearance on 1981-06-23 under 510(k) number K811230. 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 X-CELL X-RAY #'S P-75W/P-75M?

X-CELL X-RAY #'S P-75W/P-75M is a medical device that received FDA 510(k) clearance on 1981-06-23. The listed applicant is X-Cel X-Ray Corp.. The 510(k) number is K811230.

When did X-CELL X-RAY #'S P-75W/P-75M receive FDA 510(k) clearance?

X-CELL X-RAY #'S P-75W/P-75M received FDA 510(k) clearance on 1981-06-23, under 510(k) number K811230.

Who is the listed applicant for X-CELL X-RAY #'S P-75W/P-75M?

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

What is the FDA product code for X-CELL X-RAY #'S P-75W/P-75M?

The FDA product code for X-CELL X-RAY #'S P-75W/P-75M is KPR.

Other records listing X-Cel X-Ray 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.

K993958IDX-60 INTRAORAL X-RAYK930699M6-MK871116X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R

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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