PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).

System, X-ray, Extraoral Source, Digital

PROGENY, INC.

The following data is part of a premarket notification filed by Progeny, Inc. with the FDA for Progeny Imaging Software, Model# 500-405 (6,7,8)..

Pre-market Notification Details

• Device ID: K070664
• 510k Number: K070664
• Device Name: PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).
• Classification: System, X-ray, Extraoral Source, Digital
• Applicant: PROGENY, INC. 1407 BARCLAY BLVD. Buffalo Grove, IL 60089
• Contact: Alan Krema
• Correspondent: Alan Krema; PROGENY, INC. 1407 BARCLAY BLVD. Buffalo Grove, IL 60089
• Product Code: MUH
• CFR Regulation Number: 872.1800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-03-09
• Decision Date: 2007-04-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841709105661	K070664	000
00841709101410	K070664	000
00841709101403	K070664	000
00841709101397	K070664	000
00841709101380	K070664	000
00841709101373	K070664	000