Question 1

What types of medical devices does Flow X-Ray Corp. manufacture?

Accepted Answer

Flow X-Ray Corp. specializes in radiation protection equipment for medical and dental imaging. Their product line includes lead-lined radiation shielding aprons, reusable patient shielding pads or drapes, dental X-ray film (both screen and non-screen types), and X-ray intensifying screens. These devices are designed to minimize radiation exposure for both healthcare professionals and patients during X-ray procedures.

Question 2

Where is Flow X-Ray Corp. based, and what regulatory regions do their devices serve?

Accepted Answer

Flow X-Ray Corp. is based in the United States. Their devices are intended for use in the US market and are listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and identify medical devices regulated by the FDA. The company’s products comply with applicable US regulatory requirements for radiation shielding and imaging materials.

Question 3

Which regulatory registries or databases list Flow X-Ray Corp.’s devices?

Accepted Answer

Flow X-Ray Corp.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to identify medical devices throughout their distribution and helps ensure traceability and regulatory compliance. This listing applies to all their products, which are classified as Class I devices.

Question 4

How are Flow X-Ray Corp.’s devices classified under medical device regulations?

Accepted Answer

Flow X-Ray Corp.’s devices are classified as Class I medical devices. Class I devices are generally considered to pose the lowest risk and often involve minimal regulation beyond general controls. This classification applies to their radiation shielding equipment, including aprons, drapes, and X-ray film, as these products are designed to protect against radiation exposure without requiring invasive procedures or significant risk.

Device	Model / Reference	Registries	Class	Status
OR Quick Drop Apron Light Weight Lead	68094LW-25	FDA UDI	Class I	Active
Easy Wrap Apron, Lead .5mm 24" X 40"	65021-37	FDA UDI	Class I	Active
Easy Wrap Apron, Lead .5mm 26" X 42"	65027-19	FDA UDI	Class I	Active
Xpress: Fv-54 Econo Pak	18207	FDA UDI	Class I	Unknown
Thyroid Collar No Lead, .25mm 5" X 27"	75056NL-16	FDA UDI	Class I	Active
Front Closing Spec. Procedure Apron, Standard Lead	68095-40	FDA UDI	Class I	Active
Pediatric Front Closing Special Procedure Apron, Medium, 12" x 29"	69002-20	FDA UDI	Class I	Active
Fv-58 Adult Fresh Pak	18620	FDA UDI	Class I	Active
PureLife X-Ray Film	1200504	FDA UDI	Class I	Active
Coat Apron, Lead .5mm 25 X 40	63012-37	FDA UDI	Class I	Active
Conventional Lead Apron .5mm Xtra Large 25 X 40	62020-12	FDA UDI	Class I	Active
Film 6 X 12 Green Sensitive Panoramic	18096G-E	FDA UDI	Class I	Active
Apron and Vest, Ladies Xtra Large	66080-40	FDA UDI	Class I	Active
Film Dv-58 Pet Dent Wolf D Speed Size 2	31200	FDA UDI	Class I	Active
Special Procedure Apron, Standard Lead, Small	67086-36	FDA UDI	Class I	Active
Front Closing Spec. Procedure Apron, Standard Lead	68096-23	FDA UDI	Class I	Active
Front Closing Special Procedure, Lead, Medium	68093-14	FDA UDI	Class I	Active
Flow Medical X-Ray Protective Gloves	K791522	FDA 510(k)	Class I	Active
The Envision Intraoral Dental X-Ray Machines (wall Mounted And Mobile)	K052422	FDA 510(k)	Class II	Active

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