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FDA 510(k)

PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)

K-Number: K951372 · 1995-05-04

ApplicantPhilips Medical Systems, Inc.
Decision Date1995-05-04
Product CodeIZW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems, Inc.. It received FDA 510(k) clearance on 1995-05-04 under 510(k) number K951372. The device is classified under product code IZW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)?

PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) is a medical device that received FDA 510(k) clearance on 1995-05-04. The listed applicant is Philips Medical Systems, Inc.. The 510(k) number is K951372.

When did PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) receive FDA 510(k) clearance?

PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) received FDA 510(k) clearance on 1995-05-04, under 510(k) number K951372.

Who is the listed applicant for PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)?

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

What is the FDA product code for PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)?

The FDA product code for PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) is IZW.

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Other records listing Philips Medical Systems, 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.

K093355PCR ELEVA 1.2K090808PINNACLE3 SMARTARCK071391PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521K063783PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132AK041741M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIENK040955M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN

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Related Devices (Code: IZW)

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.

K101039SHIMADZU COLLIMATOR R-300Shimadzu Corp.K093572R650 QDASM COLLIMATOROmega Medical Imaging, Inc.K090578SHIMADZU COLLIMATOR R-30HShimadzu Corp.K091517RALCO, MODEL R225 ACSRalco S.R.L.K083029MODEL R605DASM AUTOMATIC X-RAY COLLIMATORRalco S.R.L.K072780MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATORRalco S.R.L.

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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