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FDA 510(k)

SII 360 MS

K-Number: K945708 · 1994-12-14

ApplicantScott Imaging Intl., Inc.
Decision Date1994-12-14
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SII 360 MS is the device name listed in this FDA 510(k) record. The listed applicant is Scott Imaging Intl., Inc.. It received FDA 510(k) clearance on 1994-12-14 under 510(k) number K945708. 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 SII 360 MS?

SII 360 MS is a medical device that received FDA 510(k) clearance on 1994-12-14. The listed applicant is Scott Imaging Intl., Inc.. The 510(k) number is K945708.

When did SII 360 MS receive FDA 510(k) clearance?

SII 360 MS received FDA 510(k) clearance on 1994-12-14, under 510(k) number K945708.

Who is the listed applicant for SII 360 MS?

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

What is the FDA product code for SII 360 MS?

The FDA product code for SII 360 MS is KPR.

Other records listing Scott Imaging Intl., 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.

K946260NTBS-1417, 1436, TBS-1417K950041SII 360 APRK950040SII 525 APRK946261MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000K946262EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLESK945709SII 525 MS

View all 7 devices →

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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