510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801573Substantially Equivalent

Sapcrill Thermodetect Breast Scanner Dev

California Cardiac Systems, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801573 is the FDA 510(k) clearance record for SAPCRILL THERMODETECT BREAST SCANNER DEV, a class I device, cleared for California Cardiac Systems, Inc. on under FDA product code KYZ (Syringe, Irrigating (Non Dental)). FDA records list one 510(k) clearance for California Cardiac Systems, Inc. As of , FDA records show no recalls naming K801573.

Clearance record

Decision date
Received
(62 days to decision)
Product code
KYZ Syringe, Irrigating (Non Dental)
Regulation
21 CFR 880.6960
Device class
Class I
Review panel
General Hospital
Applicant
California Cardiac Systems, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KYZ

Trailing 12 months

FDA records hold no clearances under product code KYZ in the trailing twelve months.

FDA records show no clearances under product code KYZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KYZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260