Model 37-185

Q: When was Model 37-185 cleared by the FDA?

Model 37-185 (K973960) received a 510(k) decision of Substantially Equivalent on January 14, 1998, 90 days after the submission was received.

Q: What is the product code of K973960?

The FDA product code is LHN – System, Radiation Therapy, Charged-Particle, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.

FDA 510(k) K973960 · Victoreen, Inc.

Substantially Equivalent

510(k) numberK973960

Submission

Device name: Model 37-185
Applicant: Victoreen, Inc.
Solon, OH, US
Received: October 16, 1997
Decision date: January 14, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LHN – System, Radiation Therapy, Charged-Particle, Medical
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.5050
Specialty: Radiology

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K220883	Small Field ApplicatorLHN · Traditional	Hitachi, Ltd. Radiation Oncology Systems…	12/15/2022SE

More from Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

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K964952	Veridose V (Five), Model Number 37-705JAD · Traditional	07/21/1997SE
K964785	Veridose DiodesIYE · Traditional	06/13/1997SE
K971382	Prone Breast Positioning Board, Model #37-018IYE · Traditional	06/06/1997SE
K952233	Clear-Pb Lead Plastic Overhead Barrier 56-628EAK · Traditional	06/16/1995SE
K940660	Model 37-720 Dual Diode Dosimetry SystemIYE · Traditional	12/09/1994SE
K935435	Nuclear Assoc 37-08 Ser, Raycast HP Radio Immob SystIYE · Traditional	07/29/1994SE
K941931	Diagnostic X-Ray Patient Exposure IndicatorKPR · Traditional	05/26/1994SE
K934549	All-Vue Ultra-Lite Thin Wall Syringe ShieldIWR · Traditional	02/19/1994SE

Questions and answers

When was Model 37-185 cleared by the FDA?

Model 37-185 (K973960) received a 510(k) decision of Substantially Equivalent on January 14, 1998, 90 days after the submission was received.

What is the product code of K973960?

The FDA product code is LHN – System, Radiation Therapy, Charged-Particle, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.