3D DISTORTION PHANTOM MANUFACTURED BY CORTECHS LABS, INC.

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Request for Information Form	Contact Information
Company Name	CORTECHS LABS, INC.
Address	1020 PROSPECT ST., SUITE 304
City, State, Zip	LA JOLLA, CA 92037
Country	US
FDA Owner/Operator Phone	858-459-9702
FDA Medical Specialty Code	RA - Radiology
FDA Product Code	IXF
FDA Classification Name	TEST-PATTERN, RADIOGRAPHIC
FDA Device Classification Code	General Controls
FDA Regulation Number	892.1940
FDA Common Generic Name	3D DISTORTION PHANTOM
FDA Proprietary Device Name	3D DISTORTION PHANTOM
FDA Owner / Operator Number	9046543
FDA Owner / Operator Name	CORTECHS LABS, INC.
FDA Establishment Registration Number	1226773
FDA Registered Establishment Name	CORTECHS LABS, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-28-04
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	BIODEX MEDICAL SYSTEMS, INC. 20 RAMSAY RD. SHIRLEY, NY 11967 US 631-924-9000 / 631-924-9000 2343	MULTIPLE	TEST PATTERNS
2	DATA SPECTRUM CORP. 437 DIMMOCKS MILL RD. HILLSBOROUGH, NC 27278 US 919-732-6800 / 919-732-6800	MULTIPLE	TEST PATTERNS
3	FLUKE BIOMEDICAL, LLC 6045 COCHRAN RD. SOLON, OH 44139 US 425-347-6100 / 440-498-2579	MULTIPLE	TEST-PATTERN, RADIOGRAPHIC
4	GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. WAUKESHA, WI 53188 US 847-277-5002 / 262-544-3894	MULTIPLE	PENETROMETERS, TEST PATTERNS, STEP WEDGES
5	MEDTEC 1401 8TH ST. S.E. ORANGE CITY, IA 51041 US 712-737-8688 / 712-737-8688	GRID TRAY	GRID TRAY
6	RADIATION PRODUCTS DESIGN, INC. 5218 BARTHEL INDUSTRIAL DR. ALBERTVILLE, MN 55301 US 763-497-2071 / 763-497-2071	MULTIPLE	VARIOUS LOCALIZING CROSS TRAYS
7	THE PHANTOM LABORATORY, INC. 2727 STATE ROUTE 29 GREENWICH, NY 12834 US 518-692-1190 / 800-525-1190	MULTIPLE	VARIOUS TYPES OF RADIOGRAPHIC TEST-PATTERN DEVICES
8	USA INSTRUMENTS, INC. 1515 DANNER DR. AURORA, OH 44202 US 847-277-5002 / 330-995-8572	PHANTOM	PHANTOM